Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 10:51 PM
Study NCT ID:
NCT04827134
Status:
COMPLETED
Last Update Posted:
2023-06-05
First Post:
2021-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000631408', 'term': 'abacavir, dolutegravir, and lamivudine drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'ViiV Healthcare'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality, Serious Adverse Events (SAEs) and non-SAEs were collected up to 23 days.', 'description': 'All-cause mortality, SAEs and non-SAEs were reported for Safety Population that consisted of all participants who received at least one dose of study intervention. Adverse events were presented treatment-wise.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 3, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 1, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Angular cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cohort 1: Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinity (AUC [0-inf]) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}], 'classes': [{'title': 'DTG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59140', 'spread': '25.7', 'groupId': 'OG000'}, {'value': '67210', 'spread': '24.0', 'groupId': 'OG001'}]}]}, {'title': 'ABC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8565', 'spread': '24.9', 'groupId': 'OG000'}, {'value': '9986', 'spread': '28.8', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6508', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '7295', 'spread': '23.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.8800', 'ciLowerLimit': '0.8344', 'ciUpperLimit': '0.9282', 'estimateComment': 'An analysis of variance (ANOVA) was performed on parameter AUC(0-inf) for Analyte DTG to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.8578', 'ciLowerLimit': '0.8168', 'ciUpperLimit': '0.9007', 'estimateComment': 'An analysis of variance was performed on parameter AUC(0-inf) for Analyte ABC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.8919', 'ciLowerLimit': '0.8316', 'ciUpperLimit': '0.9566', 'estimateComment': 'An analysis of variance was performed on parameter AUC(0-inf) for Analyte 3TC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis', 'unitOfMeasure': 'Hours*nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Parameter Population consisted of all participants who underwent plasma PK sampling and had evaluable (non-missing) PK parameters estimated. Only those participants with data available at specified time point were analyzed.'}, {'type': 'PRIMARY', 'title': 'Cohort 1: AUC From Time Zero to Time of Last Observed Quantifiable Concentration (AUC [0-t]) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '55770', 'spread': '23.8', 'groupId': 'OG000'}, {'value': '63790', 'spread': '22.7', 'groupId': 'OG001'}]}]}, {'title': 'ABC', 'categories': [{'measurements': [{'value': '8501', 'spread': '25.4', 'groupId': 'OG000'}, {'value': '9923', 'spread': '28.9', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '6319', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '7182', 'spread': '23.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.8744', 'ciLowerLimit': '0.8293', 'ciUpperLimit': '0.9219', 'estimateComment': 'An analysis of variance was performed on parameter AUC(0-t) for Analyte DTG to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.8567', 'ciLowerLimit': '0.8159', 'ciUpperLimit': '0.8995', 'estimateComment': 'An analysis of variance was performed on parameter AUC(0-t) for Analyte ABC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.8798', 'ciLowerLimit': '0.8202', 'ciUpperLimit': '0.9438', 'estimateComment': 'An analysis of variance was performed on parameter AUC(0-t) for Analyte 3TC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.', 'unitOfMeasure': 'Hours*nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Parameter Population'}, {'type': 'PRIMARY', 'title': 'Cohort 1: Maximum Observed Concentration (Cmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '2359', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '3322', 'spread': '20.6', 'groupId': 'OG001'}]}]}, {'title': 'ABC', 'categories': [{'measurements': [{'value': '1837', 'spread': '21.1', 'groupId': 'OG000'}, {'value': '4080', 'spread': '32.3', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '886.9', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '1392', 'spread': '33.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.7102', 'ciLowerLimit': '0.6598', 'ciUpperLimit': '0.7643', 'estimateComment': 'An analysis of variance was performed on parameter Cmax for Analyte DTG to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.4503', 'ciLowerLimit': '0.3976', 'ciUpperLimit': '0.5100', 'estimateComment': 'An analysis of variance was performed on parameter Cmax for Analyte ABC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.6373', 'ciLowerLimit': '0.5594', 'ciUpperLimit': '0.7260', 'estimateComment': 'An analysis of variance was performed on parameter Cmax for Analyte 3TC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.', 'unitOfMeasure': 'Nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Parameter Population'}, {'type': 'PRIMARY', 'title': 'Cohort 2: AUC (0-inf) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study.'}, {'id': 'OG001', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '47830', 'spread': '24.2', 'groupId': 'OG000'}, {'value': '51800', 'spread': '24.3', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '6975', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '7864', 'spread': '13.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9148', 'ciLowerLimit': '0.8834', 'ciUpperLimit': '0.9472', 'estimateComment': 'An analysis of variance was performed on parameter AUC(0-inf) for Analyte DTG to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.8847', 'ciLowerLimit': '0.8303', 'ciUpperLimit': '0.9426', 'estimateComment': 'An analysis of variance was performed on parameter AUC(0-inf) for Analyte 3TC to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.', 'unitOfMeasure': 'Hours*nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Cohort 2: AUC (0-t) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG001', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '46060', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '49690', 'spread': '22.0', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '6799', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '7762', 'spread': '14.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9163', 'ciLowerLimit': '0.8862', 'ciUpperLimit': '0.9475', 'estimateComment': 'An analysis of variance was performed on parameter AUC(0-t) for Analyte DTG to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.8806', 'ciLowerLimit': '0.8251', 'ciUpperLimit': '0.9398', 'estimateComment': 'An analysis of variance was performed on parameter AUC(0-t) for Analyte 3TC to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.', 'unitOfMeasure': 'Hours*nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Parameter Population'}, {'type': 'PRIMARY', 'title': 'Cohort 2: Cmax of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG001', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '2331', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '3131', 'spread': '19.8', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '1084', 'spread': '18.6', 'groupId': 'OG000'}, {'value': '2066', 'spread': '28.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.7284', 'ciLowerLimit': '0.6576', 'ciUpperLimit': '0.8068', 'estimateComment': 'An analysis of variance was performed on parameter Cmax for Analyte DTG to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.5191', 'ciLowerLimit': '0.4535', 'ciUpperLimit': '0.5943', 'estimateComment': 'An analysis of variance was performed on parameter Cmax for Analyte 3TC to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.', 'unitOfMeasure': 'Nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Parameter Population'}, {'type': 'SECONDARY', 'title': 'Cohort 1: Lag Time for Absorption (Tlag) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.000', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': 'ABC', 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.000', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.000', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Parameter Population'}, {'type': 'SECONDARY', 'title': 'Cohort 1: Terminal Elimination Phase Half-life (t1/2) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}], 'classes': [{'title': 'DTG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.18', 'spread': '21.0', 'groupId': 'OG000'}, {'value': '16.10', 'spread': '18.3', 'groupId': 'OG001'}]}]}, {'title': 'ABC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.291', 'spread': '23.9', 'groupId': 'OG000'}, {'value': '1.958', 'spread': '28.4', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.35', 'spread': '43.3', 'groupId': 'OG000'}, {'value': '15.23', 'spread': '52.9', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Cohort 1: AUC From Time Zero to 24 Hours (AUC[0-24]) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '36380', 'spread': '19.4', 'groupId': 'OG000'}, {'value': '43870', 'spread': '20.1', 'groupId': 'OG001'}]}]}, {'title': 'ABC', 'categories': [{'measurements': [{'value': '8553', 'spread': '24.8', 'groupId': 'OG000'}, {'value': '9980', 'spread': '28.8', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '5817', 'spread': '18.1', 'groupId': 'OG000'}, {'value': '6707', 'spread': '24.4', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.', 'unitOfMeasure': 'Hours*nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Parameter Population'}, {'type': 'SECONDARY', 'title': 'Cohort 1: Last Quantifiable Concentration (Ct) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '122.2', 'spread': '69.6', 'groupId': 'OG000'}, {'value': '128.6', 'spread': '60.6', 'groupId': 'OG001'}]}]}, {'title': 'ABC', 'categories': [{'measurements': [{'value': '10.61', 'spread': '164.7', 'groupId': 'OG000'}, {'value': '17.51', 'spread': '124.9', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '5.280', 'spread': '32.3', 'groupId': 'OG000'}, {'value': '4.621', 'spread': '20.3', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.', 'unitOfMeasure': 'Nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Parameter Population'}, {'type': 'SECONDARY', 'title': 'Cohort 1: Concentration at 24 Hours Post-dose (C24) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}], 'classes': [{'title': 'DTG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '958.6', 'spread': '28.3', 'groupId': 'OG000'}, {'value': '996.3', 'spread': '26.3', 'groupId': 'OG001'}]}]}, {'title': 'ABC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.833', 'spread': '52.3', 'groupId': 'OG000'}, {'value': '3.814', 'spread': '27.2', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.40', 'spread': '24.4', 'groupId': 'OG000'}, {'value': '21.74', 'spread': '23.1', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '24 hours post dose in treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.', 'unitOfMeasure': 'Nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Cohort 1: Time of Maximum Observed Concentration (Tmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '5.000', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '12.00'}, {'value': '1.250', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '4.00'}]}]}, {'title': 'ABC', 'categories': [{'measurements': [{'value': '2.750', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '4.00'}, {'value': '0.500', 'groupId': 'OG001', 'lowerLimit': '0.25', 'upperLimit': '1.50'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '3.500', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '4.00'}, {'value': '1.508', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '3.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Parameter Population'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Tlag of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study.'}, {'id': 'OG001', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.000', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.000', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Parameter Population'}, {'type': 'SECONDARY', 'title': 'Cohort 2: t1/2 of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG001', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '14.43', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '15.12', 'spread': '19.0', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '18.47', 'spread': '28.8', 'groupId': 'OG000'}, {'value': '18.36', 'spread': '21.0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: AUC(0-24) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG001', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '32620', 'spread': '19.2', 'groupId': 'OG000'}, {'value': '35360', 'spread': '15.6', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '6339', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '7339', 'spread': '14.9', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.', 'unitOfMeasure': 'Hours*nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Parameter Population'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Ct of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG001', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '82.37', 'spread': '59.6', 'groupId': 'OG000'}, {'value': '79.73', 'spread': '74.5', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '4.078', 'spread': '29.6', 'groupId': 'OG000'}, {'value': '3.622', 'spread': '25.4', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.', 'unitOfMeasure': 'Nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: C24 of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG001', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '764.7', 'spread': '28.5', 'groupId': 'OG000'}, {'value': '715.4', 'spread': '27.7', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '22.56', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '20.38', 'spread': '18.6', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '24 hours post dose in treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.', 'unitOfMeasure': 'Nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Parameter Population'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Tmax of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG001', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '4.000', 'groupId': 'OG000', 'lowerLimit': '3.50', 'upperLimit': '8.00'}, {'value': '0.875', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '3.50'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '3.000', 'groupId': 'OG000', 'lowerLimit': '0.75', 'upperLimit': '4.00'}, {'value': '0.750', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '1.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Parameter Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 23 days', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per Medical or scientific judgment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population consisted of all participants who received at least one dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'Basophils', 'categories': [{'measurements': [{'value': '-0.002', 'spread': '0.0105', 'groupId': 'OG000'}, {'value': '-0.004', 'spread': '0.0141', 'groupId': 'OG001'}, {'value': '-0.003', 'spread': '0.0100', 'groupId': 'OG002'}, {'value': '0.001', 'spread': '0.0144', 'groupId': 'OG003'}]}]}, {'title': 'Eosinophils', 'categories': [{'measurements': [{'value': '-0.002', 'spread': '0.0456', 'groupId': 'OG000'}, {'value': '0.015', 'spread': '0.0755', 'groupId': 'OG001'}, {'value': '-0.005', 'spread': '0.0219', 'groupId': 'OG002'}, {'value': '0.006', 'spread': '0.0318', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocytes', 'categories': [{'measurements': [{'value': '-0.212', 'spread': '0.3773', 'groupId': 'OG000'}, {'value': '-0.116', 'spread': '0.2271', 'groupId': 'OG001'}, {'value': '-0.027', 'spread': '0.2865', 'groupId': 'OG002'}, {'value': '-0.066', 'spread': '0.3669', 'groupId': 'OG003'}]}]}, {'title': 'Monocytes', 'categories': [{'measurements': [{'value': '-0.051', 'spread': '0.0972', 'groupId': 'OG000'}, {'value': '-0.048', 'spread': '0.0802', 'groupId': 'OG001'}, {'value': '-0.064', 'spread': '0.1285', 'groupId': 'OG002'}, {'value': '-0.021', 'spread': '0.1169', 'groupId': 'OG003'}]}]}, {'title': 'Platelet count', 'categories': [{'measurements': [{'value': '3.2', 'spread': '16.05', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '15.40', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '23.00', 'groupId': 'OG002'}, {'value': '5.5', 'spread': '19.96', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophil', 'categories': [{'measurements': [{'value': '0.031', 'spread': '0.5042', 'groupId': 'OG000'}, {'value': '-0.159', 'spread': '0.6044', 'groupId': 'OG001'}, {'value': '-0.109', 'spread': '0.9421', 'groupId': 'OG002'}, {'value': '-0.133', 'spread': '0.9317', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.', 'unitOfMeasure': '10^9 cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.008', 'spread': '0.1891', 'groupId': 'OG000'}, {'value': '-0.006', 'spread': '0.1832', 'groupId': 'OG001'}, {'value': '0.024', 'spread': '0.2141', 'groupId': 'OG002'}, {'value': '0.018', 'spread': '0.1620', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected to analyze the hematology parameter: RBC count. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.', 'unitOfMeasure': '10^12 cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematology Parameters: Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '5.66', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '4.96', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '6.40', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '5.17', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.', 'unitOfMeasure': 'Grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematology Parameters: Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study.'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0001', 'spread': '0.01647', 'groupId': 'OG000'}, {'value': '0.0003', 'spread': '0.01587', 'groupId': 'OG001'}, {'value': '0.0006', 'spread': '0.01950', 'groupId': 'OG002'}, {'value': '0.0010', 'spread': '0.01487', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.', 'unitOfMeasure': 'Proportion of red blood cells in blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study.'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.665', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.571', 'groupId': 'OG001'}, {'value': '-0.28', 'spread': '0.471', 'groupId': 'OG002'}, {'value': '-0.14', 'spread': '0.672', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: erythrocytes mean corpuscular Volume. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.', 'unitOfMeasure': 'Femtoliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.267', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '0.307', 'groupId': 'OG001'}, {'value': '0.13', 'spread': '0.442', 'groupId': 'OG002'}, {'value': '-0.09', 'spread': '0.351', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.', 'unitOfMeasure': 'Picograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'Baseline (Day -1): Basophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.040', 'spread': '0.0210', 'groupId': 'OG000'}, {'value': '0.043', 'spread': '0.0202', 'groupId': 'OG001'}, {'value': '0.042', 'spread': '0.0144', 'groupId': 'OG002'}, {'value': '0.041', 'spread': '0.0200', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: Basophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.038', 'spread': '0.0223', 'groupId': 'OG000'}, {'value': '0.039', 'spread': '0.0169', 'groupId': 'OG001'}, {'value': '0.039', 'spread': '0.0131', 'groupId': 'OG002'}, {'value': '0.042', 'spread': '0.0176', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1): Eosinophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.192', 'spread': '0.0821', 'groupId': 'OG000'}, {'value': '0.190', 'spread': '0.1081', 'groupId': 'OG001'}, {'value': '0.147', 'spread': '0.0956', 'groupId': 'OG002'}, {'value': '0.150', 'spread': '0.0922', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: Eosinophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.190', 'spread': '0.0989', 'groupId': 'OG000'}, {'value': '0.205', 'spread': '0.1231', 'groupId': 'OG001'}, {'value': '0.144', 'spread': '0.1022', 'groupId': 'OG002'}, {'value': '0.156', 'spread': '0.1050', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1): Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.002', 'spread': '0.5419', 'groupId': 'OG000'}, {'value': '1.908', 'spread': '0.4189', 'groupId': 'OG001'}, {'value': '2.029', 'spread': '0.5486', 'groupId': 'OG002'}, {'value': '2.008', 'spread': '0.5350', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.790', 'spread': '0.3956', 'groupId': 'OG000'}, {'value': '1.793', 'spread': '0.3677', 'groupId': 'OG001'}, {'value': '1.922', 'spread': '0.5003', 'groupId': 'OG002'}, {'value': '1.941', 'spread': '0.5713', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1): Monocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.461', 'spread': '0.2078', 'groupId': 'OG000'}, {'value': '0.449', 'spread': '0.1554', 'groupId': 'OG001'}, {'value': '0.507', 'spread': '0.1661', 'groupId': 'OG002'}, {'value': '0.469', 'spread': '0.1018', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: Monocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.409', 'spread': '0.1335', 'groupId': 'OG000'}, {'value': '0.402', 'spread': '0.1373', 'groupId': 'OG001'}, {'value': '0.435', 'spread': '0.1185', 'groupId': 'OG002'}, {'value': '0.448', 'spread': '0.1222', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1): Platelet count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '272.4', 'spread': '66.59', 'groupId': 'OG000'}, {'value': '276.8', 'spread': '69.88', 'groupId': 'OG001'}, {'value': '253.9', 'spread': '56.34', 'groupId': 'OG002'}, {'value': '243.1', 'spread': '54.54', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: Platelet count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '275.6', 'spread': '65.27', 'groupId': 'OG000'}, {'value': '283.5', 'spread': '64.14', 'groupId': 'OG001'}, {'value': '249.8', 'spread': '42.35', 'groupId': 'OG002'}, {'value': '248.6', 'spread': '55.33', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1): Neutrophil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.299', 'spread': '1.2456', 'groupId': 'OG000'}, {'value': '3.407', 'spread': '1.1862', 'groupId': 'OG001'}, {'value': '3.436', 'spread': '1.3351', 'groupId': 'OG002'}, {'value': '3.436', 'spread': '1.0628', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: Neutrophil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.329', 'spread': '0.9590', 'groupId': 'OG000'}, {'value': '3.248', 'spread': '0.8036', 'groupId': 'OG001'}, {'value': '3.275', 'spread': '1.4198', 'groupId': 'OG002'}, {'value': '3.304', 'spread': '1.5065', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.', 'unitOfMeasure': '10^9 cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Absolute Values of Hematology Parameters: RBC Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study.'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'Baseline (Day -1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.648', 'spread': '0.4082', 'groupId': 'OG000'}, {'value': '4.684', 'spread': '0.3549', 'groupId': 'OG001'}, {'value': '4.765', 'spread': '0.4251', 'groupId': 'OG002'}, {'value': '4.848', 'spread': '0.3975', 'groupId': 'OG003'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.656', 'spread': '0.4170', 'groupId': 'OG000'}, {'value': '4.678', 'spread': '0.4011', 'groupId': 'OG001'}, {'value': '4.839', 'spread': '0.4405', 'groupId': 'OG002'}, {'value': '4.865', 'spread': '0.4051', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameters: RBC count. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.', 'unitOfMeasure': '10^12 cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Absolute Values of Hematology Parameters: Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study.'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'Baseline (Day -1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '133.5', 'spread': '16.66', 'groupId': 'OG000'}, {'value': '134.4', 'spread': '15.71', 'groupId': 'OG001'}, {'value': '142.0', 'spread': '11.69', 'groupId': 'OG002'}, {'value': '144.5', 'spread': '11.25', 'groupId': 'OG003'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '133.8', 'spread': '16.66', 'groupId': 'OG000'}, {'value': '133.3', 'spread': '16.97', 'groupId': 'OG001'}, {'value': '144.3', 'spread': '12.06', 'groupId': 'OG002'}, {'value': '144.4', 'spread': '10.57', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.', 'unitOfMeasure': 'Grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Absolute Values of Hematology Parameters: Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study.'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'Baseline (Day -1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.3957', 'spread': '0.04371', 'groupId': 'OG000'}, {'value': '0.3976', 'spread': '0.03892', 'groupId': 'OG001'}, {'value': '0.4163', 'spread': '0.03383', 'groupId': 'OG002'}, {'value': '0.4227', 'spread': '0.03075', 'groupId': 'OG003'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.3956', 'spread': '0.04208', 'groupId': 'OG000'}, {'value': '0.3979', 'spread': '0.04358', 'groupId': 'OG001'}, {'value': '0.4201', 'spread': '0.03339', 'groupId': 'OG002'}, {'value': '0.4237', 'spread': '0.03137', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.', 'unitOfMeasure': 'Proportion of red blood cells in blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study.'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'Baseline (Day -1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '85.11', 'spread': '5.706', 'groupId': 'OG000'}, {'value': '84.92', 'spread': '5.749', 'groupId': 'OG001'}, {'value': '87.64', 'spread': '5.684', 'groupId': 'OG002'}, {'value': '87.45', 'spread': '5.795', 'groupId': 'OG003'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '85.02', 'spread': '5.470', 'groupId': 'OG000'}, {'value': '85.04', 'spread': '5.712', 'groupId': 'OG001'}, {'value': '87.09', 'spread': '5.648', 'groupId': 'OG002'}, {'value': '87.31', 'spread': '5.612', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: erythrocytes mean corpuscular Volume. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.', 'unitOfMeasure': 'Femtoliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'Baseline (Day -1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28.74', 'spread': '2.549', 'groupId': 'OG000'}, {'value': '28.71', 'spread': '2.655', 'groupId': 'OG001'}, {'value': '29.89', 'spread': '2.246', 'groupId': 'OG002'}, {'value': '29.89', 'spread': '2.210', 'groupId': 'OG003'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28.71', 'spread': '2.544', 'groupId': 'OG000'}, {'value': '28.48', 'spread': '2.592', 'groupId': 'OG001'}, {'value': '29.92', 'spread': '2.260', 'groupId': 'OG002'}, {'value': '29.80', 'spread': '2.241', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.', 'unitOfMeasure': 'Picograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'ALT', 'categories': [{'measurements': [{'value': '4.0', 'spread': '12.63', 'groupId': 'OG000'}, {'value': '-5.1', 'spread': '7.02', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '4.10', 'groupId': 'OG002'}, {'value': '-3.6', 'spread': '5.06', 'groupId': 'OG003'}]}]}, {'title': 'ALP', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '5.71', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '6.80', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '4.51', 'groupId': 'OG002'}, {'value': '-1.6', 'spread': '4.15', 'groupId': 'OG003'}]}]}, {'title': 'AST', 'categories': [{'measurements': [{'value': '0.6', 'spread': '6.69', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '4.59', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '1.70', 'groupId': 'OG002'}, {'value': '-2.0', 'spread': '3.44', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected to analyze the clinical chemistry parameters: ALT, ALP and AST. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.', 'unitOfMeasure': 'International units per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'Calcium', 'categories': [{'measurements': [{'value': '-0.003', 'spread': '0.0436', 'groupId': 'OG000'}, {'value': '-0.034', 'spread': '0.0781', 'groupId': 'OG001'}, {'value': '0.029', 'spread': '0.0792', 'groupId': 'OG002'}, {'value': '0.038', 'spread': '0.0674', 'groupId': 'OG003'}]}]}, {'title': 'Glucose', 'categories': [{'measurements': [{'value': '-0.037', 'spread': '0.2700', 'groupId': 'OG000'}, {'value': '-0.169', 'spread': '0.3648', 'groupId': 'OG001'}, {'value': '-0.047', 'spread': '0.2156', 'groupId': 'OG002'}, {'value': '-0.049', 'spread': '0.4082', 'groupId': 'OG003'}]}]}, {'title': 'Potassium', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.244', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.189', 'groupId': 'OG001'}, {'value': '-0.13', 'spread': '0.277', 'groupId': 'OG002'}, {'value': '-0.08', 'spread': '0.434', 'groupId': 'OG003'}]}]}, {'title': 'Sodium', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.29', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '1.41', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '1.40', 'groupId': 'OG003'}]}]}, {'title': 'BUN', 'categories': [{'measurements': [{'value': '0.208', 'spread': '0.4826', 'groupId': 'OG000'}, {'value': '0.293', 'spread': '0.8664', 'groupId': 'OG001'}, {'value': '0.353', 'spread': '0.8394', 'groupId': 'OG002'}, {'value': '0.445', 'spread': '0.9233', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: calcium, glucose, potassium, sodium and BUN. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.', 'unitOfMeasure': 'Millimoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'Creatinine', 'categories': [{'measurements': [{'value': '9.18', 'spread': '2.871', 'groupId': 'OG000'}, {'value': '10.76', 'spread': '4.045', 'groupId': 'OG001'}, {'value': '1.83', 'spread': '2.931', 'groupId': 'OG002'}, {'value': '2.11', 'spread': '5.796', 'groupId': 'OG003'}]}]}, {'title': 'Direct Bilirubin', 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.541', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.398', 'groupId': 'OG001'}, {'value': '0.04', 'spread': '0.403', 'groupId': 'OG002'}, {'value': '-0.06', 'spread': '0.330', 'groupId': 'OG003'}]}]}, {'title': 'Total Bilirubin', 'categories': [{'measurements': [{'value': '0.16', 'spread': '3.069', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '2.712', 'groupId': 'OG001'}, {'value': '0.58', 'spread': '2.377', 'groupId': 'OG002'}, {'value': '-0.03', 'spread': '1.588', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: creatinine, direct bilirubin and total bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.', 'unitOfMeasure': 'Micromoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Chemistry Parameters: Creatine Kinase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.8', 'spread': '47.62', 'groupId': 'OG000'}, {'value': '-51.9', 'spread': '82.52', 'groupId': 'OG001'}, {'value': '-33.9', 'spread': '44.83', 'groupId': 'OG002'}, {'value': '-29.5', 'spread': '91.10', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: creatine kinase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.', 'unitOfMeasure': 'International units per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Chemistry Parameters: Albumin and Total Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'Albumin', 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '3.20', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '2.55', 'groupId': 'OG002'}, {'value': '1.1', 'spread': '1.67', 'groupId': 'OG003'}]}]}, {'title': 'Total Protein', 'categories': [{'measurements': [{'value': '0.9', 'spread': '3.07', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '4.59', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '3.58', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '3.32', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: albumin and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.', 'unitOfMeasure': 'Grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'Baseline (Day -1): ALT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.7', 'spread': '9.16', 'groupId': 'OG000'}, {'value': '24.3', 'spread': '15.10', 'groupId': 'OG001'}, {'value': '23.4', 'spread': '16.38', 'groupId': 'OG002'}, {'value': '24.8', 'spread': '15.45', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: ALT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.7', 'spread': '18.71', 'groupId': 'OG000'}, {'value': '19.3', 'spread': '9.69', 'groupId': 'OG001'}, {'value': '22.6', 'spread': '16.01', 'groupId': 'OG002'}, {'value': '21.1', 'spread': '14.24', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1) ALP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '66.8', 'spread': '15.23', 'groupId': 'OG000'}, {'value': '65.6', 'spread': '17.65', 'groupId': 'OG001'}, {'value': '59.3', 'spread': '13.58', 'groupId': 'OG002'}, {'value': '61.8', 'spread': '14.65', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: ALP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '64.1', 'spread': '16.18', 'groupId': 'OG000'}, {'value': '62.6', 'spread': '14.47', 'groupId': 'OG001'}, {'value': '60.1', 'spread': '13.85', 'groupId': 'OG002'}, {'value': '60.2', 'spread': '13.16', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1): AST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.4', 'spread': '5.26', 'groupId': 'OG000'}, {'value': '20.6', 'spread': '5.77', 'groupId': 'OG001'}, {'value': '18.5', 'spread': '6.97', 'groupId': 'OG002'}, {'value': '18.9', 'spread': '6.57', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: AST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.0', 'spread': '8.82', 'groupId': 'OG000'}, {'value': '16.6', 'spread': '2.94', 'groupId': 'OG001'}, {'value': '17.3', 'spread': '6.04', 'groupId': 'OG002'}, {'value': '16.9', 'spread': '5.11', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected to analyze the clinical chemistry parameters: ALT, ALP and AST. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.', 'unitOfMeasure': 'International units per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'Baseline (Day -1): Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.350', 'spread': '0.1030', 'groupId': 'OG000'}, {'value': '2.376', 'spread': '0.0975', 'groupId': 'OG001'}, {'value': '2.339', 'spread': '0.0793', 'groupId': 'OG002'}, {'value': '2.333', 'spread': '0.0981', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.347', 'spread': '0.0899', 'groupId': 'OG000'}, {'value': '2.342', 'spread': '0.0980', 'groupId': 'OG001'}, {'value': '2.368', 'spread': '0.0742', 'groupId': 'OG002'}, {'value': '2.371', 'spread': '0.0721', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1): Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.821', 'spread': '0.3214', 'groupId': 'OG000'}, {'value': '5.016', 'spread': '0.3793', 'groupId': 'OG001'}, {'value': '4.974', 'spread': '0.3943', 'groupId': 'OG002'}, {'value': '5.068', 'spread': '0.4760', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.784', 'spread': '0.2407', 'groupId': 'OG000'}, {'value': '4.848', 'spread': '0.2820', 'groupId': 'OG001'}, {'value': '4.943', 'spread': '0.4349', 'groupId': 'OG002'}, {'value': '5.019', 'spread': '0.3243', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1): Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.11', 'spread': '0.268', 'groupId': 'OG000'}, {'value': '4.16', 'spread': '0.239', 'groupId': 'OG001'}, {'value': '4.33', 'spread': '0.335', 'groupId': 'OG002'}, {'value': '4.31', 'spread': '0.330', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.14', 'spread': '0.216', 'groupId': 'OG000'}, {'value': '4.18', 'spread': '0.224', 'groupId': 'OG001'}, {'value': '4.23', 'spread': '0.235', 'groupId': 'OG002'}, {'value': '4.23', 'spread': '0.298', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1): Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '137.8', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '137.9', 'spread': '1.67', 'groupId': 'OG001'}, {'value': '138.5', 'spread': '1.59', 'groupId': 'OG002'}, {'value': '138.8', 'spread': '1.73', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '138.3', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '138.8', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '138.2', 'spread': '1.47', 'groupId': 'OG002'}, {'value': '139.1', 'spread': '1.61', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1): BUN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.531', 'spread': '0.9081', 'groupId': 'OG000'}, {'value': '4.333', 'spread': '1.0302', 'groupId': 'OG001'}, {'value': '4.633', 'spread': '0.9609', 'groupId': 'OG002'}, {'value': '4.592', 'spread': '1.3875', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: BUN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.739', 'spread': '0.7250', 'groupId': 'OG000'}, {'value': '4.626', 'spread': '0.8416', 'groupId': 'OG001'}, {'value': '5.065', 'spread': '1.0791', 'groupId': 'OG002'}, {'value': '5.037', 'spread': '1.0406', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: calcium, glucose, potassium, sodium and BUN. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.', 'unitOfMeasure': 'Millimoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'Baseline (Day -1): Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '74.38', 'spread': '14.598', 'groupId': 'OG000'}, {'value': '75.10', 'spread': '15.407', 'groupId': 'OG001'}, {'value': '80.18', 'spread': '12.794', 'groupId': 'OG002'}, {'value': '82.54', 'spread': '9.056', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '83.55', 'spread': '15.394', 'groupId': 'OG000'}, {'value': '85.86', 'spread': '16.173', 'groupId': 'OG001'}, {'value': '83.87', 'spread': '10.444', 'groupId': 'OG002'}, {'value': '84.65', 'spread': '10.814', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1): Direct Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.88', 'spread': '0.886', 'groupId': 'OG000'}, {'value': '1.88', 'spread': '0.748', 'groupId': 'OG001'}, {'value': '1.74', 'spread': '0.271', 'groupId': 'OG002'}, {'value': '1.84', 'spread': '0.505', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: Direct Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.04', 'spread': '0.776', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '0.767', 'groupId': 'OG001'}, {'value': '1.80', 'spread': '0.539', 'groupId': 'OG002'}, {'value': '1.78', 'spread': '0.437', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1): Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.33', 'spread': '4.305', 'groupId': 'OG000'}, {'value': '10.63', 'spread': '4.326', 'groupId': 'OG001'}, {'value': '9.90', 'spread': '2.286', 'groupId': 'OG002'}, {'value': '10.55', 'spread': '3.109', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.49', 'spread': '3.560', 'groupId': 'OG000'}, {'value': '9.89', 'spread': '3.747', 'groupId': 'OG001'}, {'value': '10.73', 'spread': '3.405', 'groupId': 'OG002'}, {'value': '10.52', 'spread': '3.040', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: creatinine, direct bilirubin and total bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.', 'unitOfMeasure': 'Micromoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Absolute Values of Clinical Chemistry Parameters: Creatine Kinase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'Baseline (Day -1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '111.5', 'spread': '66.68', 'groupId': 'OG000'}, {'value': '143.8', 'spread': '110.57', 'groupId': 'OG001'}, {'value': '119.7', 'spread': '59.78', 'groupId': 'OG002'}, {'value': '124.6', 'spread': '117.54', 'groupId': 'OG003'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '93.7', 'spread': '47.08', 'groupId': 'OG000'}, {'value': '91.8', 'spread': '53.25', 'groupId': 'OG001'}, {'value': '86.6', 'spread': '34.64', 'groupId': 'OG002'}, {'value': '95.1', 'spread': '44.21', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: creatine kinase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.', 'unitOfMeasure': 'International units per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'Baseline (Day -1): Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '44.0', 'spread': '3.31', 'groupId': 'OG000'}, {'value': '44.5', 'spread': '3.58', 'groupId': 'OG001'}, {'value': '43.0', 'spread': '2.57', 'groupId': 'OG002'}, {'value': '42.9', 'spread': '2.59', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '44.2', 'spread': '2.81', 'groupId': 'OG000'}, {'value': '43.6', 'spread': '2.83', 'groupId': 'OG001'}, {'value': '43.7', 'spread': '2.63', 'groupId': 'OG002'}, {'value': '44.1', 'spread': '2.86', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1): Total Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '71.3', 'spread': '3.82', 'groupId': 'OG000'}, {'value': '71.8', 'spread': '3.64', 'groupId': 'OG001'}, {'value': '69.1', 'spread': '4.32', 'groupId': 'OG002'}, {'value': '69.4', 'spread': '4.36', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: Total Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '72.2', 'spread': '3.04', 'groupId': 'OG000'}, {'value': '71.6', 'spread': '2.90', 'groupId': 'OG001'}, {'value': '69.6', 'spread': '4.08', 'groupId': 'OG002'}, {'value': '70.1', 'spread': '4.91', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: albumin and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.', 'unitOfMeasure': 'Grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urinalysis Parameter: Specific Gravity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0034', 'spread': '0.00650', 'groupId': 'OG000'}, {'value': '0.0013', 'spread': '0.01116', 'groupId': 'OG001'}, {'value': '0.0029', 'spread': '0.00809', 'groupId': 'OG002'}, {'value': '0.0019', 'spread': '0.00570', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': "Urine samples were collected at Baseline and at Day 4 post dose of each period to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.", 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.34', 'spread': '0.724', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.547', 'groupId': 'OG001'}, {'value': '-0.13', 'spread': '0.645', 'groupId': 'OG002'}, {'value': '-0.44', 'spread': '0.512', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Urine samples were collected at Baseline and at Day 4 post dose of each period to analyze the urinalysis parameter: pH by dipstick. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.', 'unitOfMeasure': 'pH', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Absolute Values of Urinalysis Parameter: Specific Gravity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'Baseline (Day -1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0128', 'spread': '0.00767', 'groupId': 'OG000'}, {'value': '1.0134', 'spread': '0.00766', 'groupId': 'OG001'}, {'value': '1.0151', 'spread': '0.00800', 'groupId': 'OG002'}, {'value': '1.0163', 'spread': '0.00857', 'groupId': 'OG003'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0162', 'spread': '0.00782', 'groupId': 'OG000'}, {'value': '1.0147', 'spread': '0.00921', 'groupId': 'OG001'}, {'value': '1.0182', 'spread': '0.00727', 'groupId': 'OG002'}, {'value': '1.0181', 'spread': '0.00851', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': "Urine samples were collected at Baseline and at Day 4 post dose of each period to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.", 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Absolute Values of Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'Baseline (Day -1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.38', 'spread': '0.806', 'groupId': 'OG000'}, {'value': '6.22', 'spread': '0.515', 'groupId': 'OG001'}, {'value': '6.41', 'spread': '0.643', 'groupId': 'OG002'}, {'value': '6.50', 'spread': '0.548', 'groupId': 'OG003'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.03', 'spread': '0.499', 'groupId': 'OG000'}, {'value': '6.00', 'spread': '0.577', 'groupId': 'OG001'}, {'value': '6.28', 'spread': '0.605', 'groupId': 'OG002'}, {'value': '6.06', 'spread': '0.544', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Urine samples were collected at Baseline and at Day 4 post dose of each period to analyze the urinalysis parameter: pH by dipstick. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.', 'unitOfMeasure': 'pH', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Values on Urinalysis by Dipstick', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'Baseline (Day -1): Urine Glucose (Negative)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: Urine Glucose (Negative)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1): Urine Protein (Negative)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: Urine Protein (Negative)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1): Urine Blood (Negative)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1): Urine Blood (3+)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1): Urine Blood (2+)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1): Urine Blood (Trace)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: Urine Blood (Negative)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: Urine Blood (2+)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: Urine Blood (3+)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1): Urine Ketones (Negative)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: Urine Ketones (Negative)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: Urine Ketones (1+)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, and ketones by dipstick. The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present) indicating proportional concentrations in the urine sample.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT Interval According to Fridericia's Formula (QTcF)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'PR Interval', 'categories': [{'measurements': [{'value': '2.2', 'spread': '9.70', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '12.39', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '9.90', 'groupId': 'OG002'}, {'value': '4.0', 'spread': '5.69', 'groupId': 'OG003'}]}]}, {'title': 'QRS Duration', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '3.35', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '4.44', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '2.99', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '3.23', 'groupId': 'OG003'}]}]}, {'title': 'QT Interval', 'categories': [{'measurements': [{'value': '-10.5', 'spread': '15.80', 'groupId': 'OG000'}, {'value': '-6.4', 'spread': '17.20', 'groupId': 'OG001'}, {'value': '-13.1', 'spread': '11.26', 'groupId': 'OG002'}, {'value': '-2.4', 'spread': '13.86', 'groupId': 'OG003'}]}]}, {'title': 'QTcF', 'categories': [{'measurements': [{'value': '-4.1', 'spread': '11.87', 'groupId': 'OG000'}, {'value': '-6.9', 'spread': '11.21', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '8.71', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '6.10', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Single 12-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval and QTcF Interval. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.', 'unitOfMeasure': 'Milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'Baseline (Day -1): PR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '163.4', 'spread': '24.29', 'groupId': 'OG000'}, {'value': '161.6', 'spread': '23.91', 'groupId': 'OG001'}, {'value': '174.6', 'spread': '25.55', 'groupId': 'OG002'}, {'value': '176.1', 'spread': '21.82', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: PR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '165.6', 'spread': '23.35', 'groupId': 'OG000'}, {'value': '160.9', 'spread': '24.82', 'groupId': 'OG001'}, {'value': '174.8', 'spread': '17.72', 'groupId': 'OG002'}, {'value': '180.1', 'spread': '19.48', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1): QRS Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '95.6', 'spread': '8.66', 'groupId': 'OG000'}, {'value': '96.7', 'spread': '10.62', 'groupId': 'OG001'}, {'value': '93.4', 'spread': '8.12', 'groupId': 'OG002'}, {'value': '93.1', 'spread': '7.27', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: QRS Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '94.4', 'spread': '8.38', 'groupId': 'OG000'}, {'value': '93.8', 'spread': '10.36', 'groupId': 'OG001'}, {'value': '93.8', 'spread': '7.48', 'groupId': 'OG002'}, {'value': '93.2', 'spread': '7.53', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1): QT Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '401.8', 'spread': '21.90', 'groupId': 'OG000'}, {'value': '400.7', 'spread': '21.35', 'groupId': 'OG001'}, {'value': '407.5', 'spread': '23.85', 'groupId': 'OG002'}, {'value': '402.2', 'spread': '25.69', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: QT Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '391.3', 'spread': '15.10', 'groupId': 'OG000'}, {'value': '394.3', 'spread': '19.00', 'groupId': 'OG001'}, {'value': '392.9', 'spread': '20.51', 'groupId': 'OG002'}, {'value': '399.8', 'spread': '25.41', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '400.1', 'spread': '14.30', 'groupId': 'OG000'}, {'value': '403.6', 'spread': '14.51', 'groupId': 'OG001'}, {'value': '400.1', 'spread': '17.84', 'groupId': 'OG002'}, {'value': '401.3', 'spread': '16.99', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: QTcF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '395.9', 'spread': '14.26', 'groupId': 'OG000'}, {'value': '396.6', 'spread': '13.34', 'groupId': 'OG001'}, {'value': '395.6', 'spread': '19.23', 'groupId': 'OG002'}, {'value': '400.4', 'spread': '18.54', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Single 12-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval and QTcF Interval. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.', 'unitOfMeasure': 'Milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Signs Measurements: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'SBP', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '4.32', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '6.71', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '8.14', 'groupId': 'OG002'}, {'value': '0.6', 'spread': '8.54', 'groupId': 'OG003'}]}]}, {'title': 'DBP', 'categories': [{'measurements': [{'value': '0.0', 'spread': '7.27', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '5.20', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '6.46', 'groupId': 'OG002'}, {'value': '-1.1', 'spread': '8.71', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'SBP and DBP were measured in the supine or semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.', 'unitOfMeasure': 'Millimeters of mercury', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Absolute Values of Vital Signs Measurements: SBP and DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'Baseline (Day -1): SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '110.6', 'spread': '10.61', 'groupId': 'OG000'}, {'value': '113.0', 'spread': '10.04', 'groupId': 'OG001'}, {'value': '112.5', 'spread': '9.37', 'groupId': 'OG002'}, {'value': '113.5', 'spread': '8.65', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '109.5', 'spread': '10.93', 'groupId': 'OG000'}, {'value': '108.8', 'spread': '9.07', 'groupId': 'OG001'}, {'value': '114.7', 'spread': '9.14', 'groupId': 'OG002'}, {'value': '114.1', 'spread': '10.67', 'groupId': 'OG003'}]}]}, {'title': 'Baseline (Day -1): DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '64.0', 'spread': '7.68', 'groupId': 'OG000'}, {'value': '64.0', 'spread': '7.69', 'groupId': 'OG001'}, {'value': '63.0', 'spread': '7.37', 'groupId': 'OG002'}, {'value': '66.4', 'spread': '6.55', 'groupId': 'OG003'}]}]}, {'title': 'Day 4: DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '64.0', 'spread': '9.12', 'groupId': 'OG000'}, {'value': '64.3', 'spread': '8.99', 'groupId': 'OG001'}, {'value': '66.4', 'spread': '8.06', 'groupId': 'OG002'}, {'value': '65.3', 'spread': '8.20', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'SBP and DBP were measured in the supine or semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.', 'unitOfMeasure': 'Millimeters of mercury', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Signs Measurements: Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '5.18', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '5.87', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '10.12', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '7.04', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Pulse rate were measured in the supine or semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Absolute Values of Vital Signs Measurements: Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 1 of study'}, {'id': 'OG001', 'title': 'Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 1 of study.'}, {'id': 'OG002', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) during Treatment Periods 1 and 2 of Cohort 2 of study'}, {'id': 'OG003', 'title': 'Cohort 2: DOVATO (DTG/3TC) Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions during Treatment Periods 1 and 2 of Cohort 2 of study.'}], 'classes': [{'title': 'Baseline (Day -1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '59.9', 'spread': '9.07', 'groupId': 'OG000'}, {'value': '62.3', 'spread': '7.49', 'groupId': 'OG001'}, {'value': '59.9', 'spread': '10.82', 'groupId': 'OG002'}, {'value': '60.1', 'spread': '8.44', 'groupId': 'OG003'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '62.9', 'spread': '8.47', 'groupId': 'OG000'}, {'value': '62.0', 'spread': '9.89', 'groupId': 'OG001'}, {'value': '61.4', 'spread': '3.86', 'groupId': 'OG002'}, {'value': '59.9', 'spread': '6.68', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Pulse rate were measured in the supine or semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: TRIUMEQ Fed Followed by TRIUMEQ Fasted', 'description': 'Participants received TRIUMEQ (dolutegravir \\[DTG\\] 5 milligram \\[mg\\]/abacavir \\[ABC\\] 60 mg/lamivudine \\[3TC\\] 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment A) in treatment period 1 followed by TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment B) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.'}, {'id': 'FG001', 'title': 'Cohort 1: TRIUMEQ Fasted Followed by TRIUMEQ Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment B) in treatment period 1 followed by TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment A) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.'}, {'id': 'FG002', 'title': 'Cohort 2: DOVATO Fed Followed by DOVATO Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment C) in treatment period 1 followed by DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment D) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.'}, {'id': 'FG003', 'title': 'Cohort 2: DOVATO Fasted Followed by DOVATO Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment D) in treatment period 1 followed by DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment C) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.'}], 'periods': [{'title': 'Treatment Period 1 (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout Period (up to 7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2 (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at a single center in the United States.', 'preAssignmentDetails': 'A total of 33 participants (16 participants in Cohort 1 and 17 participants in Cohort 2) were enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: TRIUMEQ Fed Followed by TRIUMEQ Fasted', 'description': 'Participants received TRIUMEQ (dolutegravir \\[DTG\\] 5 milligram \\[mg\\]/abacavir \\[ABC\\] 60 mg/lamivudine \\[3TC\\] 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment A) in treatment period 1 followed by TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment B) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.'}, {'id': 'BG001', 'title': 'Cohort 1: TRIUMEQ Fasted Followed by TRIUMEQ Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment B) in treatment period 1 followed by TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment A) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.'}, {'id': 'BG002', 'title': 'Cohort 2: DOVATO Fed Followed by DOVATO Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment C) in treatment period 1 followed by DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment D) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.'}, {'id': 'BG003', 'title': 'Cohort 2: DOVATO Fasted Followed by DOVATO Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment D) in treatment period 1 followed by DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment C) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '19-64 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian: Central/South Asian Heritage', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': 'Multiple: Black or African American & White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-04', 'size': 2898916, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-06-08T02:26', 'hasProtocol': True}, {'date': '2021-06-07', 'size': 947748, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-30T05:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open-label study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is a randomized, single-dose, 2-cohort, 2-period crossover study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-21', 'studyFirstSubmitDate': '2021-03-23', 'resultsFirstSubmitDate': '2022-07-21', 'studyFirstSubmitQcDate': '2021-03-31', 'lastUpdatePostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-21', 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cohort 1: Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinity (AUC [0-inf]) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis'}, {'measure': 'Cohort 1: AUC From Time Zero to Time of Last Observed Quantifiable Concentration (AUC [0-t]) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.'}, {'measure': 'Cohort 1: Maximum Observed Concentration (Cmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.'}, {'measure': 'Cohort 2: AUC (0-inf) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.'}, {'measure': 'Cohort 2: AUC (0-t) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.'}, {'measure': 'Cohort 2: Cmax of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.'}], 'secondaryOutcomes': [{'measure': 'Cohort 1: Lag Time for Absorption (Tlag) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.'}, {'measure': 'Cohort 1: Terminal Elimination Phase Half-life (t1/2) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.'}, {'measure': 'Cohort 1: AUC From Time Zero to 24 Hours (AUC[0-24]) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.'}, {'measure': 'Cohort 1: Last Quantifiable Concentration (Ct) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.'}, {'measure': 'Cohort 1: Concentration at 24 Hours Post-dose (C24) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions', 'timeFrame': '24 hours post dose in treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.'}, {'measure': 'Cohort 1: Time of Maximum Observed Concentration (Tmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.'}, {'measure': 'Cohort 2: Tlag of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.'}, {'measure': 'Cohort 2: t1/2 of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.'}, {'measure': 'Cohort 2: AUC(0-24) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.'}, {'measure': 'Cohort 2: Ct of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.'}, {'measure': 'Cohort 2: C24 of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions', 'timeFrame': '24 hours post dose in treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.'}, {'measure': 'Cohort 2: Tmax of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions', 'timeFrame': 'Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 Hours post dose in each treatment periods 1 and 2', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.'}, {'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 23 days', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per Medical or scientific judgment.'}, {'measure': 'Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.'}, {'measure': 'Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected to analyze the hematology parameter: RBC count. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.'}, {'measure': 'Change From Baseline in Hematology Parameters: Hemoglobin', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.'}, {'measure': 'Change From Baseline in Hematology Parameters: Hematocrit', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.'}, {'measure': 'Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: erythrocytes mean corpuscular Volume. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.'}, {'measure': 'Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.'}, {'measure': 'Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.'}, {'measure': 'Absolute Values of Hematology Parameters: RBC Count', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameters: RBC count. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.'}, {'measure': 'Absolute Values of Hematology Parameters: Hemoglobin', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.'}, {'measure': 'Absolute Values of Hematology Parameters: Hematocrit', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.'}, {'measure': 'Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Volume', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: erythrocytes mean corpuscular Volume. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.'}, {'measure': 'Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.'}, {'measure': 'Change From Baseline in Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST)', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected to analyze the clinical chemistry parameters: ALT, ALP and AST. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.'}, {'measure': 'Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN)', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: calcium, glucose, potassium, sodium and BUN. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.'}, {'measure': 'Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: creatinine, direct bilirubin and total bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.'}, {'measure': 'Change From Baseline in Clinical Chemistry Parameters: Creatine Kinase', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: creatine kinase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.'}, {'measure': 'Change From Baseline in Clinical Chemistry Parameters: Albumin and Total Protein', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: albumin and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.'}, {'measure': 'Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected to analyze the clinical chemistry parameters: ALT, ALP and AST. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.'}, {'measure': 'Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: calcium, glucose, potassium, sodium and BUN. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.'}, {'measure': 'Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: creatinine, direct bilirubin and total bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.'}, {'measure': 'Absolute Values of Clinical Chemistry Parameters: Creatine Kinase', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: creatine kinase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.'}, {'measure': 'Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Blood samples were collected at Baseline and at Day 4 post dose of each period to analyze the clinical chemistry parameters: albumin and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.'}, {'measure': 'Change From Baseline in Urinalysis Parameter: Specific Gravity', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': "Urine samples were collected at Baseline and at Day 4 post dose of each period to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value."}, {'measure': 'Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Urine samples were collected at Baseline and at Day 4 post dose of each period to analyze the urinalysis parameter: pH by dipstick. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.'}, {'measure': 'Absolute Values of Urinalysis Parameter: Specific Gravity', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': "Urine samples were collected at Baseline and at Day 4 post dose of each period to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits."}, {'measure': 'Absolute Values of Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Urine samples were collected at Baseline and at Day 4 post dose of each period to analyze the urinalysis parameter: pH by dipstick. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.'}, {'measure': 'Number of Participants With Abnormal Values on Urinalysis by Dipstick', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, and ketones by dipstick. The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present) indicating proportional concentrations in the urine sample.'}, {'measure': "Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT Interval According to Fridericia's Formula (QTcF)", 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Single 12-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval and QTcF Interval. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.'}, {'measure': 'Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Single 12-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval and QTcF Interval. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.'}, {'measure': 'Change From Baseline in Vital Signs Measurements: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'SBP and DBP were measured in the supine or semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.'}, {'measure': 'Absolute Values of Vital Signs Measurements: SBP and DBP', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'SBP and DBP were measured in the supine or semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.'}, {'measure': 'Change From Baseline in Vital Signs Measurements: Pulse Rate', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Pulse rate were measured in the supine or semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.'}, {'measure': 'Absolute Values of Vital Signs Measurements: Pulse Rate', 'timeFrame': 'Baseline (Day -1) and Day 4', 'description': 'Pulse rate were measured in the supine or semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TRIUMEQ', 'DOVATO', 'Pharmacokinetics', 'Food effect', 'Dolutegravir', 'Abacavir', 'Lamivudine'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'This study will assess the effect of food on the pharmacokinetics (PK) of pediatric formulations of TRIUMEQ (dolutegravir \\[DTG\\] 5 milligrams \\[mg\\]/abacavir \\[ABC\\] 60 mg/lamivudine \\[3TC\\] 30 mg) dispersible tablets and DOVATO (DTG 5 mg/3TC 30 mg) dispersible tablets in healthy adult participants. Additionally, safety and tolerability of these formulations will also be assessed. TRIUMEQ and DOVATO are registered trademarks of GlaxoSmithKline group of companies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent.\n* Participants who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).\n* Body weight \\>=50.0 kilograms (kg) (110 pounds \\[lbs.\\]) for males and \\>=45 kg (99 lbs.) for females and body mass index within the range 18.5 to 31.0 kilogram per meter square (kg/m\\^2, inclusive).\n* A male participant is eligible to participate if they agree to use contraceptive methods.\n* A female participant is eligible to participate if she is not pregnant (, not lactating or breastfeeding, and at least 1 of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and using a non-hormonal contraceptive method that is highly effective\n* Capable of giving signed informed consent\n* Documentation that the participant is negative for the human leukocyte antigen (HLA) B\\*5701 allele.\n\nExclusion Criteria:\n\n* Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).\n* Medical history of cardiac arrhythmias, prior myocardial infarction in the past 3 months, or cardiac disease or a family or personal history of long QT syndrome.\n* A pre-existing condition interfering with normal gastrointestinal anatomy or motility (e.g., gastroesophageal reflux disease, gastric ulcers, gastritis), hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study intervention.\n* QT interval corrected for heart rate according to Fridericia's formula (QTcF) \\>450 milliseconds (msec).\n* A participant with known or suspected active coronavirus disease (COVID-19) infection OR contact with an individual with known COVID-19, within 14 days of study enrollment.\n* Presence of hepatitis B surface antigen at screening or within 3 months prior to starting study intervention.\n* Positive hepatitis C antibody test result at screening or within 3 months prior to starting study intervention AND positive on reflex to hepatitis C ribonucleic acid (RNA).\n* Positive human immunodeficiency virus (HIV)-1 and -2 antigen/antibody immunoassay at screening.\n* Alanine aminotransferase (ALT) \\>1.5 × upper limit of normal (ULN). A single repeat of ALT is allowed within a single screening period to determine eligibility.\n* Bilirubin \\>1.5 × ULN (isolated bilirubin \\>1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin \\<35%). A single repeat of any laboratory abnormality is allowed within a single screening period to determine eligibility.\n* Any acute laboratory abnormality at screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound.\n* Any Grade 2 to 4 laboratory abnormality at screening, with the exception of creatine phosphokinase (CPK) and lipid abnormalities (e.g., total cholesterol, triglycerides), and ALT (described above), will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the sponsor. A single repeat of any laboratory abnormality is allowed within a single screening period to determine eligibility.\n* A positive test result for drugs of abuse (including marijuana), alcohol, or cotinine (indicating active current smoking) at screening or before the first dose of study intervention.\n* Unable to refrain from the use of prescription or non-prescription drugs including vitamins, herbal and dietary supplements (including St. John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study intervention and for the duration of the study until completion of the follow-up visit, unless, in the opinion of the investigator and ViiV Healthcare (VH)/GlaxoSmithKline medical monitor, the medication will not interfere with the study procedures or compromise participant safety.\n* Unwillingness to abstain from excessive consumption of any food or drink containing grapefruit and grapefruit juice, Seville oranges, blood oranges, or pomelos or their fruit juices within 7 days prior to the first dose of study intervention(s) until the end of the study.\n* Participation in another concurrent clinical study or prior clinical study (with the exception of imaging trials) prior to Day 1 of Period 1 in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the study intervention (whichever is longer).\n* Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within 60 days.\n* Estimated serum creatinine clearance (Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\]) \\<90 milliliter per minute (mL/min).\n* History of regular alcohol consumption within 6 months of the study, defined as an average weekly intake of \\>14 units for males or \\>7 drinks for females.\n* Unable to refrain from tobacco or nicotine-containing products within 1 month prior to screening.\n* History of sensitivity, prior intolerance or hypersensitivity to any of the study interventions, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation."}, 'identificationModule': {'nctId': 'NCT04827134', 'briefTitle': 'A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'A Randomized, 2-Cohort, 2-Period, Single Dose, Crossover Clinical Study to Assess the Effect of Food on the Pediatric Dispersible Tablet Formulations of TRIUMEQ (Dolutegravir/Abacavir/Lamivudine) and DOVATO (Dolutegravir/Lamivudine) in Healthy Adult Participants', 'orgStudyIdInfo': {'id': '216149'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: TRIUMEQ Fed followed by TRIUMEQ Fasted', 'description': 'Participants received TRIUMEQ (dolutegravir \\[DTG\\] 5 milligram \\[mg\\]/abacavir \\[ABC\\] 60 mg/lamivudine \\[3TC\\] 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment A) in treatment period 1 followed by TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment B) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.', 'interventionNames': ['Drug: TRIUMEQ']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1: TRIUMEQ Fasted followed by TRIUMEQ Fed', 'description': 'Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment B) in treatment period 1 followed by TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment A) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.', 'interventionNames': ['Drug: TRIUMEQ']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: DOVATO Fed followed by DOVATO Fasted', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment C) in treatment period 1 followed by DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment D) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.', 'interventionNames': ['Drug: DOVATO']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: DOVATO Fasted followed by DOVATO Fed', 'description': 'Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment D) in treatment period 1 followed by DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment C) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2.', 'interventionNames': ['Drug: DOVATO']}], 'interventions': [{'name': 'TRIUMEQ', 'type': 'DRUG', 'description': 'TRIUMEQ will be available as fixed dose combination (FDC) dispersible tablets to be administered orally as a dispersion.', 'armGroupLabels': ['Cohort 1: TRIUMEQ Fasted followed by TRIUMEQ Fed', 'Cohort 1: TRIUMEQ Fed followed by TRIUMEQ Fasted']}, {'name': 'DOVATO', 'type': 'DRUG', 'description': 'DOVATO will be available as FDC dispersible tablets to be administered orally as a dispersion.', 'armGroupLabels': ['Cohort 2: DOVATO Fasted followed by DOVATO Fed', 'Cohort 2: DOVATO Fed followed by DOVATO Fasted']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ViiV Healthcare'}]}, 'ipdSharingStatementModule': {'url': 'http://clinicalstudydatarequest.com', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.', 'ipdSharing': 'YES', 'description': 'IPD for this study will be made available via the Clinical Study Data Request site.', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}