Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-05 @ 6:24 PM
Study NCT ID:
NCT03078556
Status:
COMPLETED
Last Update Posted:
2019-02-21
First Post:
2017-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine
Sponsor:
Organization:
Raw JSON
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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': 'AEs and SAEs were collected from the start of study treatment until the follow-up contact (Up to 11 weeks)', 'description': 'Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1- A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 2, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part 1- B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 5, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed', 'description': 'Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part 2- A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 8, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 6, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 75, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity [AUC (0-Inf)] of Plasma DTG and 3TC in the Fasted State: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '43.1456', 'spread': '39.29', 'groupId': 'OG000'}, {'value': '54.8793', 'spread': '31.60', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '12.3337', 'spread': '19.88', 'groupId': 'OG000'}, {'value': '12.7603', 'spread': '19.77', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.2710', 'ciLowerLimit': '1.1894', 'ciUpperLimit': '1.3582', 'estimateComment': 'Ratio (B/A) of plasma DTG has been presented.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0341', 'ciLowerLimit': '1.0097', 'ciUpperLimit': '1.0591', 'estimateComment': 'Ratio (B/A) of plasma 3TC has been presented.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the pharmacokinetic (PK) profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.", 'unitOfMeasure': 'Hour*micrograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter Bioequivalence (BE) Summary Population comprised of all participants who have evaluable PK parameters for both analytes and for both Period 1 and Period 2.'}, {'type': 'PRIMARY', 'title': 'AUC (0-Inf) of Plasma DTG and 3TC in the Fasted State: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'C: DTG 50 mg/ 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG, n= 74,74', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.2391', 'spread': '40.29', 'groupId': 'OG000'}, {'value': '54.5594', 'spread': '32.12', 'groupId': 'OG001'}]}]}, {'title': '3TC, n= 73,74', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.7713', 'spread': '18.63', 'groupId': 'OG000'}, {'value': '13.5624', 'spread': '17.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.1550', 'ciLowerLimit': '1.0699', 'ciUpperLimit': '1.2468', 'estimateComment': 'Ratio (C/A) of plasma DTG has been presented.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0635', 'ciLowerLimit': '1.0413', 'ciUpperLimit': '1.0861', 'estimateComment': 'Ratio (C/A) of plasma 3TC has been presented.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at given time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted conditions in Periods 1 and 2 of Part 2.", 'unitOfMeasure': 'Hours*micrograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population. Only those participants with data available at the specified data points were analyzed, represented by n= X,X in the category titles.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Time Point (AUC[0-t]) of Plasma DTG and 3TC in the Fasted State: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '41.4207', 'spread': '39.36', 'groupId': 'OG000'}, {'value': '52.8754', 'spread': '31.16', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '12.1571', 'spread': '20.19', 'groupId': 'OG000'}, {'value': '12.6147', 'spread': '19.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.2756', 'ciLowerLimit': '1.1919', 'ciUpperLimit': '1.3651', 'estimateComment': 'Ratio (B/A) of plasma DTG has been presented.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0372', 'ciLowerLimit': '1.0116', 'ciUpperLimit': '1.0634', 'estimateComment': 'Ratio (B/A) of plasma 3TC has been presented.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.", 'unitOfMeasure': 'Hours*micrograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population.'}, {'type': 'PRIMARY', 'title': 'AUC(0-t) of Plasma DTG and 3TC in the Fasted State: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'C: DTG 50 mg/ 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '45.2043', 'spread': '39.57', 'groupId': 'OG000'}, {'value': '52.3372', 'spread': '31.46', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '12.4790', 'spread': '19.19', 'groupId': 'OG000'}, {'value': '13.3552', 'spread': '18.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.1578', 'ciLowerLimit': '1.0718', 'ciUpperLimit': '1.2507', 'estimateComment': 'Ratio (C/A) of plasma DTG has been presented.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0702', 'ciLowerLimit': '1.0464', 'ciUpperLimit': '1.0946', 'estimateComment': 'Ratio (C/A) of plasma 3TC has been presented.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.", 'unitOfMeasure': 'Hour*microgram/milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Concentration (Cmax) of Plasma DTG and 3TC in the Fasted State: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '2.4065', 'spread': '38.95', 'groupId': 'OG000'}, {'value': '3.0817', 'spread': '31.86', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '2.6650', 'spread': '29.04', 'groupId': 'OG000'}, {'value': '3.1885', 'spread': '28.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.2805', 'ciLowerLimit': '1.1890', 'ciUpperLimit': '1.3790', 'estimateComment': 'Ratio (B/A) of plasma DTG has been presented.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.1956', 'ciLowerLimit': '1.1437', 'ciUpperLimit': '1.2498', 'estimateComment': 'Ratio (B/A) of plasma 3TC has been presented.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.", 'unitOfMeasure': 'Micrograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population'}, {'type': 'PRIMARY', 'title': 'Cmax of Plasma DTG and 3TC in the Fasted State: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'B: DTG 50 mg/ 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50mg and 3TC 300mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '2.5531', 'spread': '36.38', 'groupId': 'OG000'}, {'value': '2.9132', 'spread': '30.55', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '2.4428', 'spread': '28.25', 'groupId': 'OG000'}, {'value': '3.2185', 'spread': '29.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.1410', 'ciLowerLimit': '1.0533', 'ciUpperLimit': '1.2361', 'estimateComment': 'Ratio (C/A) of plasma DTG has been presented.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.3176', 'ciLowerLimit': '1.2616', 'ciUpperLimit': '1.3760', 'estimateComment': 'Ratio (C/A) of plasma 3TC has been presented.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.", 'unitOfMeasure': 'Micrograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population'}, {'type': 'SECONDARY', 'title': 'Absorption Lag Time (Tlag) of DTG and 3TC in Fasted State: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.756'}, {'value': '0.0000', 'groupId': 'OG001', 'lowerLimit': '0.0000', 'upperLimit': '0.261'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.252'}, {'value': '0.0000', 'groupId': 'OG001', 'lowerLimit': '0.0000', 'upperLimit': '0.261'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.000', 'ciLowerLimit': '0.000', 'ciUpperLimit': '0.000', 'estimateComment': 'Median Difference of plasma DTG has been presented.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.000', 'ciLowerLimit': '0.000', 'ciUpperLimit': '0.000', 'estimateComment': 'Median Difference of plasma 3TC has been presented.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.", 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population'}, {'type': 'SECONDARY', 'title': 'Tlag of DTG and 3TC in Fasted State: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'C: DTG 50 mg/ 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.261'}, {'value': '0.0000', 'groupId': 'OG001', 'lowerLimit': '0.0000', 'upperLimit': '0.266'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.0000'}, {'value': '0.0000', 'groupId': 'OG001', 'lowerLimit': '0.0000', 'upperLimit': '0.252'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.000', 'ciLowerLimit': '-0.004', 'ciUpperLimit': '0.000', 'estimateComment': 'Median Difference of plasma DTG has been presented.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.000', 'ciLowerLimit': '0.000', 'ciUpperLimit': '0.000', 'estimateComment': 'Median Difference of plasma 3TC has been presented.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.", 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Plasma Concentration (Tmax) of DTG and 3TC in the Fasted State: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '2.0072', 'groupId': 'OG000', 'lowerLimit': '0.500', 'upperLimit': '8.009'}, {'value': '2.0017', 'groupId': 'OG001', 'lowerLimit': '0.500', 'upperLimit': '5.012'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '1.0047', 'groupId': 'OG000', 'lowerLimit': '0.500', 'upperLimit': '4.005'}, {'value': '1.0008', 'groupId': 'OG001', 'lowerLimit': '0.500', 'upperLimit': '3.500'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.127', 'ciLowerLimit': '-0.500', 'ciUpperLimit': '0.248', 'estimateComment': 'Median Difference of plasma DTG has been presented.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.126', 'ciLowerLimit': '-0.253', 'ciUpperLimit': '-0.001', 'estimateComment': 'Median Difference of plasma 3TC has been presented.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.", 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population.'}, {'type': 'SECONDARY', 'title': 'Tmax of DTG and 3TC in the Fasted State: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'C: DTG 50 mg/ 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '2.5008', 'groupId': 'OG000', 'lowerLimit': '0.500', 'upperLimit': '5.011'}, {'value': '2.5004', 'groupId': 'OG001', 'lowerLimit': '0.500', 'upperLimit': '6.001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '1.0063', 'groupId': 'OG000', 'lowerLimit': '0.500', 'upperLimit': '4.002'}, {'value': '1.0011', 'groupId': 'OG001', 'lowerLimit': '0.500', 'upperLimit': '3.501'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.127', 'ciLowerLimit': '-0.497', 'ciUpperLimit': '0.132', 'estimateComment': 'Median Difference of plasma DTG has been presented.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.248', 'ciLowerLimit': '-0.376', 'ciUpperLimit': '-0.001', 'estimateComment': 'Median Difference of plasma 3TC has been presented.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2", 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population'}, {'type': 'SECONDARY', 'title': 'Time of the Last Quantifiable Concentration (Tlast) of DTG and 3TC in the Fasted State: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '72.0031', 'groupId': 'OG000', 'lowerLimit': '48.000', 'upperLimit': '74.636'}, {'value': '71.9303', 'groupId': 'OG001', 'lowerLimit': '48.003', 'upperLimit': '76.236'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '71.9289', 'groupId': 'OG000', 'lowerLimit': '47.673', 'upperLimit': '74.636'}, {'value': '71.9303', 'groupId': 'OG001', 'lowerLimit': '70.790', 'upperLimit': '76.236'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.", 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population'}, {'type': 'SECONDARY', 'title': 'Tlast of DTG and 3TC in the Fasted State: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'C: DTG 50 mg/ 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '71.6813', 'groupId': 'OG000', 'lowerLimit': '48.006', 'upperLimit': '75.301'}, {'value': '71.8243', 'groupId': 'OG001', 'lowerLimit': '71.005', 'upperLimit': '72.632'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '71.7138', 'groupId': 'OG000', 'lowerLimit': '48.000', 'upperLimit': '75.301'}, {'value': '71.8153', 'groupId': 'OG001', 'lowerLimit': '48.007', 'upperLimit': '72.632'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2", 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population'}, {'type': 'SECONDARY', 'title': 'Time to Reach Half the Maximum Plasma Concentration (t1/2) of DTG and 3TC in the Fasted State: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '14.6917', 'groupId': 'OG000', 'lowerLimit': '10.575', 'upperLimit': '21.375'}, {'value': '14.7557', 'groupId': 'OG001', 'lowerLimit': '10.461', 'upperLimit': '21.392'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '17.0395', 'groupId': 'OG000', 'lowerLimit': '8.281', 'upperLimit': '34.542'}, {'value': '17.3436', 'groupId': 'OG001', 'lowerLimit': '12.436', 'upperLimit': '34.675'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.", 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population'}, {'type': 'SECONDARY', 'title': 't1/2 of DTG and 3TC in the Fasted State: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'C: DTG 50 mg/ 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG, n= 74,74', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.1538', 'groupId': 'OG000', 'lowerLimit': '9.711', 'upperLimit': '21.966'}, {'value': '14.7893', 'groupId': 'OG001', 'lowerLimit': '9.815', 'upperLimit': '21.486'}]}]}, {'title': '3TC, n= 73,74', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.8421', 'groupId': 'OG000', 'lowerLimit': '10.195', 'upperLimit': '47.171'}, {'value': '18.1071', 'groupId': 'OG001', 'lowerLimit': '7.367', 'upperLimit': '48.613'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2", 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population. Only those participants with data available at the specified time points were analyzed indicated by n=X in category titles.'}, {'type': 'SECONDARY', 'title': 'Apparent Elimination Rate Constant (Lambda z) of DTG and 3TC in the Fasted State: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '0.0472', 'groupId': 'OG000', 'lowerLimit': '0.032', 'upperLimit': '0.066'}, {'value': '0.0470', 'groupId': 'OG001', 'lowerLimit': '0.032', 'upperLimit': '0.066'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '0.0407', 'groupId': 'OG000', 'lowerLimit': '0.020', 'upperLimit': '0.084'}, {'value': '0.0400', 'groupId': 'OG001', 'lowerLimit': '0.020', 'upperLimit': '0.056'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.", 'unitOfMeasure': 'Per hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population'}, {'type': 'SECONDARY', 'title': 'Lambda z of DTG and 3TC in in the Fasted State: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'C: DTG 50 mg/ 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG, n=74,74', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0457', 'groupId': 'OG000', 'lowerLimit': '0.032', 'upperLimit': '0.071'}, {'value': '0.0469', 'groupId': 'OG001', 'lowerLimit': '0.032', 'upperLimit': '0.071'}]}]}, {'title': '3TC, n= 73,74', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0388', 'groupId': 'OG000', 'lowerLimit': '0.015', 'upperLimit': '0.068'}, {'value': '0.0383', 'groupId': 'OG001', 'lowerLimit': '0.014', 'upperLimit': '0.094'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.", 'unitOfMeasure': 'Per hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population. Only those participants with data available at the specified data points were analyzed (represented by n= X,X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Percentage of Extrapolated AUC (0 to Inf) of DTG and 3TC in the Fasted State: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '3.4967', 'groupId': 'OG000', 'lowerLimit': '1.015', 'upperLimit': '15.084'}, {'value': '3.2582', 'groupId': 'OG001', 'lowerLimit': '0.908', 'upperLimit': '9.967'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '1.0287', 'groupId': 'OG000', 'lowerLimit': '0.343', 'upperLimit': '7.305'}, {'value': '0.9052', 'groupId': 'OG001', 'lowerLimit': '0.428', 'upperLimit': '5.334'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.", 'unitOfMeasure': 'Percentage of AUC', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Extrapolated AUC(0 to Inf) of DTG and 3TC in the Fasted State: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'C: DTG 50 mg/ 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG, n= 74,74', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8923', 'groupId': 'OG000', 'lowerLimit': '0.932', 'upperLimit': '10.512'}, {'value': '3.5773', 'groupId': 'OG001', 'lowerLimit': '0.659', 'upperLimit': '9.570'}]}]}, {'title': '3TC, n= 73,74', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2518', 'groupId': 'OG000', 'lowerLimit': '0.344', 'upperLimit': '6.409'}, {'value': '1.1432', 'groupId': 'OG001', 'lowerLimit': '0.394', 'upperLimit': '7.867'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.", 'unitOfMeasure': 'Percentage of AUC', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population. Only those participants with data available at the specified time points were analyzed indicated by n=X in category titles.'}, {'type': 'SECONDARY', 'title': 'AUC of 0 to 24 Hours (AUC[0-24]) of DTG and 3TC in the Fasted State: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '29.4257', 'spread': '38.40', 'groupId': 'OG000'}, {'value': '37.6112', 'spread': '30.28', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '11.3960', 'spread': '20.92', 'groupId': 'OG000'}, {'value': '11.9418', 'spread': '20.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.2774', 'ciLowerLimit': '1.1931', 'ciUpperLimit': '1.3676', 'estimateComment': 'Ratio (B/A) of plasma DTG has been presented.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0475', 'ciLowerLimit': '1.0185', 'ciUpperLimit': '1.0773', 'estimateComment': 'Ratio (B/A) of plasma 3TC has been presented.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.", 'unitOfMeasure': 'Hours*microgram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population'}, {'type': 'SECONDARY', 'title': 'AUC(0-24) of DTG and 3TC in the Fasted State: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'C: DTG 50 mg/ 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '31.5664', 'spread': '37.73', 'groupId': 'OG000'}, {'value': '36.6126', 'spread': '30.93', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '11.6419', 'spread': '20.23', 'groupId': 'OG000'}, {'value': '12.5810', 'spread': '18.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.1599', 'ciLowerLimit': '1.0711', 'ciUpperLimit': '1.2560', 'estimateComment': 'Ratio (C/A) of plasma DTG has been presented.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0807', 'ciLowerLimit': '1.0539', 'ciUpperLimit': '1.1081', 'estimateComment': 'Ratio (C/A) of plasma 3TC has been presented.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.", 'unitOfMeasure': 'Hours*microgram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population'}, {'type': 'SECONDARY', 'title': 'Apparent Oral Clearance (CL/F) of DTG and 3TC in the Fasted State: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '1.1589', 'spread': '39.29', 'groupId': 'OG000'}, {'value': '0.9111', 'spread': '31.60', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '24.3236', 'spread': '19.88', 'groupId': 'OG000'}, {'value': '23.5104', 'spread': '19.77', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.7868', 'ciLowerLimit': '0.7363', 'ciUpperLimit': '0.8408', 'estimateComment': 'Ratio (B/A) of plasma DTG has been presented.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9670', 'ciLowerLimit': '0.9442', 'ciUpperLimit': '0.9904', 'estimateComment': 'Ratio (B/A) of plasma 3TC has been presented.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.", 'unitOfMeasure': 'Liters per hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population'}, {'type': 'SECONDARY', 'title': 'CL/F of DTG and 3TC in the Fasted State: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'C: DTG 50 mg/ 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG, n= 74, 74', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0584', 'spread': '40.29', 'groupId': 'OG000'}, {'value': '0.9164', 'spread': '32.12', 'groupId': 'OG001'}]}]}, {'title': '3TC, n= 73, 74', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.4901', 'spread': '18.63', 'groupId': 'OG000'}, {'value': '22.1200', 'spread': '17.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.8658', 'ciLowerLimit': '0.8021', 'ciUpperLimit': '0.9347', 'estimateComment': 'Ratio (C/A) of plasma DTG has been presented.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9403', 'ciLowerLimit': '0.9207', 'ciUpperLimit': '0.9604', 'estimateComment': 'Ratio (C/A) of plasma 3TC has been presented.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.", 'unitOfMeasure': 'Liters per hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population. Only those participants with data available at the specified time points were analyzed represented by n=X in the category titles.'}, {'type': 'SECONDARY', 'title': 'Apparent Oral Volume of Distribution (Vz/F) of DTG and 3TC in the Fasted State: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '24.6254', 'spread': '37.80', 'groupId': 'OG000'}, {'value': '19.3399', 'spread': '30.05', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '616.7365', 'spread': '34.52', 'groupId': 'OG000'}, {'value': '598.8651', 'spread': '29.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.7859', 'ciLowerLimit': '0.7318', 'ciUpperLimit': '0.8440', 'estimateComment': 'Ratio (B/A) of plasma DTG has been presented.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9704', 'ciLowerLimit': '0.9157', 'ciUpperLimit': '1.0284', 'estimateComment': 'Ratio (B/A) of plasma 3TC has been presented.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.", 'unitOfMeasure': 'Liters', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population'}, {'type': 'SECONDARY', 'title': 'Vz/F of DTG and 3TC in the Fasted State: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'C: DTG 50 mg/ 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG, n= 74, 74', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.1159', 'spread': '37.18', 'groupId': 'OG000'}, {'value': '19.8124', 'spread': '32.73', 'groupId': 'OG001'}]}]}, {'title': '3TC, n= 73, 74', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '650.7952', 'spread': '35.55', 'groupId': 'OG000'}, {'value': '599.5525', 'spread': '34.28', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.8571', 'ciLowerLimit': '0.7914', 'ciUpperLimit': '0.9282', 'estimateComment': 'Ratio (C/A) of plasma DTG has been presented.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9153', 'ciLowerLimit': '0.8613', 'ciUpperLimit': '0.9728', 'estimateComment': 'Ratio (C/A) of plasma 3TC has been presented.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.", 'unitOfMeasure': 'Liters', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population. Only those participants with data available at the specified data points were analyzed, represented by n= X,X in the category titles.'}, {'type': 'SECONDARY', 'title': 'Concentration at 24 Hours Post-dose (C24) of DTG and 3TC in the Fasted State: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '0.6373', 'spread': '40.18', 'groupId': 'OG000'}, {'value': '0.8059', 'spread': '32.77', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '0.0331', 'spread': '32.13', 'groupId': 'OG000'}, {'value': '0.0318', 'spread': '31.81', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.2632', 'ciLowerLimit': '1.1811', 'ciUpperLimit': '1.3511', 'estimateComment': 'Ratio (B/A) of plasma DTG has been presented.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9598', 'ciLowerLimit': '0.9268', 'ciUpperLimit': '0.9941', 'estimateComment': 'Ratio (B/A) of plasma 3TC has been presented.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.", 'unitOfMeasure': 'Micrograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population.'}, {'type': 'SECONDARY', 'title': 'C24 of DTG and 3TC in the Fasted State: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'C: DTG 50 mg/ 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '0.7065', 'spread': '41.48', 'groupId': 'OG000'}, {'value': '0.8071', 'spread': '33.83', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '0.0366', 'spread': '30.39', 'groupId': 'OG000'}, {'value': '0.0350', 'spread': '31.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.1425', 'ciLowerLimit': '1.0597', 'ciUpperLimit': '1.2317', 'estimateComment': 'Ratio (C/A) of plasma DTG has been presented.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9548', 'ciLowerLimit': '0.9299', 'ciUpperLimit': '0.9804', 'estimateComment': 'Ratio (C/A) of plasma 3TC has been presented.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.", 'unitOfMeasure': 'Micrograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population'}, {'type': 'SECONDARY', 'title': 'Last Quantifiable Concentration (Clast) of DTG and 3TC in the Fasted State: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '0.0702', 'spread': '58.85', 'groupId': 'OG000'}, {'value': '0.0832', 'spread': '56.42', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '0.0056', 'spread': '43.03', 'groupId': 'OG000'}, {'value': '0.0050', 'spread': '37.58', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.1839', 'ciLowerLimit': '1.0921', 'ciUpperLimit': '1.2834', 'estimateComment': 'Ratio (B/A) of plasma DTG has been presented', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.8874', 'ciLowerLimit': '0.8340', 'ciUpperLimit': '0.9443', 'estimateComment': 'Ratio (B/A) of plasma 3TC has been presented', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.", 'unitOfMeasure': 'Micrograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population'}, {'type': 'SECONDARY', 'title': 'Clast of DTG and 3TC in the Fasted State: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'C: DTG 50 mg/ 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '0.0800', 'spread': '66.94', 'groupId': 'OG000'}, {'value': '0.0862', 'spread': '65.26', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '0.0069', 'spread': '47.83', 'groupId': 'OG000'}, {'value': '0.0062', 'spread': '41.60', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0780', 'ciLowerLimit': '0.9958', 'ciUpperLimit': '1.1670', 'estimateComment': 'Ratio (B/A) of plasma DTG has been presented', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9049', 'ciLowerLimit': '0.8474', 'ciUpperLimit': '0.9663', 'estimateComment': 'Ratio (B/A) of plasma 3TC has been presented', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.", 'unitOfMeasure': 'Micrograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter BE Summary Population'}, {'type': 'SECONDARY', 'title': 'AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'Bfed: DTG 50 mg/3TC 300 mg Monolayer FDC Fed', 'description': 'Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '62.3435', 'spread': '32.34', 'groupId': 'OG000'}, {'value': '71.9777', 'spread': '19.99', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '13.4357', 'spread': '21.02', 'groupId': 'OG000'}, {'value': '12.8668', 'spread': '18.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.1545', 'ciLowerLimit': '1.0208', 'ciUpperLimit': '1.3058', 'estimateComment': 'Ratio (Bfed/B) of plasma DTG has been presented', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9577', 'ciLowerLimit': '0.9126', 'ciUpperLimit': '1.0049', 'estimateComment': 'Ratio (Bfed/B) of plasma 3TC has been presented', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.", 'unitOfMeasure': 'Hours*microgram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter food effect (FD) Summary Population comprised of participants who participated in the food effect part of the study and had evaluable PK parameters for both fed and fasted administration of the FDC tablet formulation.'}, {'type': 'SECONDARY', 'title': 'AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C: DTG 50 mg and 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '57.6561', 'spread': '35.93', 'groupId': 'OG000'}, {'value': '76.4283', 'spread': '22.36', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '14.6420', 'spread': '18.50', 'groupId': 'OG000'}, {'value': '13.3443', 'spread': '20.34', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.3256', 'ciLowerLimit': '1.1837', 'ciUpperLimit': '1.4845', 'estimateComment': 'Ratio (Cfed/C) of plasma DTG has been presented', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9114', 'ciLowerLimit': '0.8658', 'ciUpperLimit': '0.9593', 'estimateComment': 'Ratio (Cfed/C) of plasma 3TC has been presented', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.", 'unitOfMeasure': 'Hours*microgram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter FD Summary Population'}, {'type': 'SECONDARY', 'title': 'AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed', 'description': 'Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '60.3212', 'spread': '31.78', 'groupId': 'OG000'}, {'value': '69.2560', 'spread': '18.92', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '13.2818', 'spread': '20.90', 'groupId': 'OG000'}, {'value': '12.6491', 'spread': '18.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.1481', 'ciLowerLimit': '1.0154', 'ciUpperLimit': '1.2982', 'estimateComment': 'Ratio (Bfed/B) of plasma DTG has been presented', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9524', 'ciLowerLimit': '0.9086', 'ciUpperLimit': '0.9983', 'estimateComment': 'Ratio (Bfed/B) of plasma 3TC has been presented', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.", 'unitOfMeasure': 'Hour*microgram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter FD Summary Population'}, {'type': 'SECONDARY', 'title': 'AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C: DTG 50 mg and 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '55.2176', 'spread': '35.33', 'groupId': 'OG000'}, {'value': '72.7545', 'spread': '20.22', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '14.4706', 'spread': '18.72', 'groupId': 'OG000'}, {'value': '13.0923', 'spread': '20.57', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.3176', 'ciLowerLimit': '1.1750', 'ciUpperLimit': '1.4775', 'estimateComment': 'Ratio (Cfed/C) of plasma DTG has been presented', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9048', 'ciLowerLimit': '0.8592', 'ciUpperLimit': '0.9528', 'estimateComment': 'Ratio (Cfed/C) of plasma 3TC has been presented', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.", 'unitOfMeasure': 'Hour*microgram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter FD Summary Population'}, {'type': 'SECONDARY', 'title': 'Cmax of Plasma DTG and 3TC in the Fed State: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed', 'description': 'Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '3.5068', 'spread': '30.27', 'groupId': 'OG000'}, {'value': '3.7900', 'spread': '20.97', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '3.5413', 'spread': '27.14', 'groupId': 'OG000'}, {'value': '2.5132', 'spread': '18.74', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0808', 'ciLowerLimit': '0.9527', 'ciUpperLimit': '1.2261', 'estimateComment': 'Ratio (Bfed/B) of plasma DTG has been presented', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.7097', 'ciLowerLimit': '0.6474', 'ciUpperLimit': '0.7779', 'estimateComment': 'Ratio (Bfed/B) of plasma 3TC has been presented', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.", 'unitOfMeasure': 'Micrograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter FD Summary Population'}, {'type': 'SECONDARY', 'title': 'Cmax of Plasma DTG and 3TC in the Fed State: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C: DTG 50 mg and 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '3.1015', 'spread': '35.62', 'groupId': 'OG000'}, {'value': '3.7516', 'spread': '21.31', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '3.5824', 'spread': '35.18', 'groupId': 'OG000'}, {'value': '2.4453', 'spread': '33.88', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.2096', 'ciLowerLimit': '1.0521', 'ciUpperLimit': '1.3908', 'estimateComment': 'Ratio (Cfed/C) of plasma DTG has been presented', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.6826', 'ciLowerLimit': '0.5861', 'ciUpperLimit': '0.7950', 'estimateComment': 'Ratio (Cfed/C) of plasma 3TC has been presented', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.", 'unitOfMeasure': 'Micrograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter FD Summary Population'}, {'type': 'SECONDARY', 'title': 'Tlag of DTG and 3TC in Fed State: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed', 'description': 'Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.251'}, {'value': '0.2522', 'groupId': 'OG001', 'lowerLimit': '0.0000', 'upperLimit': '1.000'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.251'}, {'value': '0.0000', 'groupId': 'OG001', 'lowerLimit': '0.0000', 'upperLimit': '0.255'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.254', 'ciLowerLimit': '0.250', 'ciUpperLimit': '0.378', 'estimateComment': 'Median Difference of plasma DTG has been presented', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.125', 'ciLowerLimit': '0.000', 'ciUpperLimit': '0.127', 'estimateComment': 'Median Difference of plasma 3TC has been presented', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.", 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter FD Summary Population'}, {'type': 'SECONDARY', 'title': 'Tlag of DTG and 3TC in Fed State: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C: DTG 50 mg and 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.258'}, {'value': '0.1253', 'groupId': 'OG001', 'lowerLimit': '0.0000', 'upperLimit': '0.751'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.252'}, {'value': '0.0000', 'groupId': 'OG001', 'lowerLimit': '0.0000', 'upperLimit': '0.257'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.126', 'ciLowerLimit': '0.000', 'ciUpperLimit': '0.250', 'estimateComment': 'Median Difference of plasma DTG has been presented', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.000', 'ciLowerLimit': '0.000', 'ciUpperLimit': '0.125', 'estimateComment': 'Median Difference of plasma 3TC has been presented', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.", 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter FD Summary Population'}, {'type': 'SECONDARY', 'title': 'Tmax of DTG and 3TC in the Fed State: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed', 'description': 'Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '1.5013', 'groupId': 'OG000', 'lowerLimit': '0.503', 'upperLimit': '5.002'}, {'value': '5.0006', 'groupId': 'OG001', 'lowerLimit': '2.001', 'upperLimit': '12.009'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '1.0001', 'groupId': 'OG000', 'lowerLimit': '0.500', 'upperLimit': '2.001'}, {'value': '3.5003', 'groupId': 'OG001', 'lowerLimit': '1.011', 'upperLimit': '5.006'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '3.017', 'ciLowerLimit': '1.872', 'ciUpperLimit': '4.496', 'estimateComment': 'Median Difference of plasma DTG has been presented', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.113', 'ciLowerLimit': '1.500', 'ciUpperLimit': '2.751', 'estimateComment': 'Median Difference of plasma 3TC has been presented', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.", 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter FD Summary Population'}, {'type': 'SECONDARY', 'title': 'Tmax of DTG and 3TC in the Fed State: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C: DTG 50 mg and 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '1.5007', 'groupId': 'OG000', 'lowerLimit': '0.751', 'upperLimit': '3.001'}, {'value': '5.0019', 'groupId': 'OG001', 'lowerLimit': '1.011', 'upperLimit': '8.004'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '1.0003', 'groupId': 'OG000', 'lowerLimit': '0.503', 'upperLimit': '2.506'}, {'value': '2.7508', 'groupId': 'OG001', 'lowerLimit': '1.001', 'upperLimit': '6.001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.500', 'ciLowerLimit': '1.748', 'ciUpperLimit': '3.751', 'estimateComment': 'Median Difference of plasma DTG has been presented', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.503', 'ciLowerLimit': '0.998', 'ciUpperLimit': '2.252', 'estimateComment': 'Median Difference of plasma 3TC has been presented', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.", 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter FD Summary Population'}, {'type': 'SECONDARY', 'title': 'T1/2 of DTG and 3TC in the Fed State: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed', 'description': 'Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '14.5843', 'groupId': 'OG000', 'lowerLimit': '12.077', 'upperLimit': '16.806'}, {'value': '14.5816', 'groupId': 'OG001', 'lowerLimit': '10.889', 'upperLimit': '17.259'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '18.3614', 'groupId': 'OG000', 'lowerLimit': '12.509', 'upperLimit': '30.759'}, {'value': '19.8579', 'groupId': 'OG001', 'lowerLimit': '9.977', 'upperLimit': '34.144'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.", 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter FD Summary Population'}, {'type': 'SECONDARY', 'title': 'T1/2 of DTG and 3TC in the Fed State: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C: DTG 50 mg and 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '14.9828', 'groupId': 'OG000', 'lowerLimit': '11.355', 'upperLimit': '20.563'}, {'value': '15.1718', 'groupId': 'OG001', 'lowerLimit': '12.193', 'upperLimit': '19.945'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '17.2250', 'groupId': 'OG000', 'lowerLimit': '13.259', 'upperLimit': '37.099'}, {'value': '19.7311', 'groupId': 'OG001', 'lowerLimit': '13.384', 'upperLimit': '27.781'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.", 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter FD Summary Population'}, {'type': 'SECONDARY', 'title': 'Lambda z of DTG and 3TC in in the Fed State: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed', 'description': 'Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '0.0475', 'groupId': 'OG000', 'lowerLimit': '0.041', 'upperLimit': '0.057'}, {'value': '0.0475', 'groupId': 'OG001', 'lowerLimit': '0.040', 'upperLimit': '0.064'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '0.0378', 'groupId': 'OG000', 'lowerLimit': '0.023', 'upperLimit': '0.055'}, {'value': '0.0349', 'groupId': 'OG001', 'lowerLimit': '0.020', 'upperLimit': '0.069'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.", 'unitOfMeasure': 'Per hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter FD Summary Population'}, {'type': 'SECONDARY', 'title': 'Lambda z of DTG and 3TC in in the Fed State: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C: DTG 50 mg and 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '0.0463', 'groupId': 'OG000', 'lowerLimit': '0.034', 'upperLimit': '0.061'}, {'value': '0.0457', 'groupId': 'OG001', 'lowerLimit': '0.035', 'upperLimit': '0.057'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '0.0403', 'groupId': 'OG000', 'lowerLimit': '0.019', 'upperLimit': '0.052'}, {'value': '0.0351', 'groupId': 'OG001', 'lowerLimit': '0.025', 'upperLimit': '0.052'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.", 'unitOfMeasure': 'Per hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter FD Summary Population'}, {'type': 'SECONDARY', 'title': 'Clast of DTG and 3TC in in the Fed State: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed', 'description': 'Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '0.1060', 'groupId': 'OG000', 'lowerLimit': '0.035', 'upperLimit': '0.180'}, {'value': '0.1190', 'groupId': 'OG001', 'lowerLimit': '0.043', 'upperLimit': '0.243'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '0.0048', 'groupId': 'OG000', 'lowerLimit': '0.003', 'upperLimit': '0.014'}, {'value': '0.0066', 'groupId': 'OG001', 'lowerLimit': '0.004', 'upperLimit': '0.016'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. 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There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '16.7520', 'spread': '28.45', 'groupId': 'OG000'}, {'value': '14.4964', 'spread': '15.87', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '593.2054', 'spread': '29.23', 'groupId': 'OG000'}, {'value': '643.0977', 'spread': '41.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.8654', 'ciLowerLimit': '0.7629', 'ciUpperLimit': '0.9816', 'estimateComment': 'Ratio (Bfed/B) of plasma DTG has been presented', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0841', 'ciLowerLimit': '0.9139', 'ciUpperLimit': '1.2860', 'estimateComment': 'Ratio (Bfed/B) of plasma 3TC has been presented', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.", 'unitOfMeasure': 'Liters', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter FD Summary Population.'}, {'type': 'SECONDARY', 'title': 'Vz/F of DTG and 3TC in the Fed State: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C: DTG 50 mg and 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '19.0954', 'spread': '36.45', 'groupId': 'OG000'}, {'value': '14.6215', 'spread': '11.63', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '535.8125', 'spread': '35.63', 'groupId': 'OG000'}, {'value': '641.3744', 'spread': '32.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.7657', 'ciLowerLimit': '0.6702', 'ciUpperLimit': '0.8749', 'estimateComment': 'Ratio (Cfed/C) of plasma DTG has been presented', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.1970', 'ciLowerLimit': '1.0869', 'ciUpperLimit': '1.3182', 'estimateComment': 'Ratio (Cfed/C) of plasma 3TC has been presented', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.", 'unitOfMeasure': 'Liters', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter FD Summary Population'}, {'type': 'SECONDARY', 'title': 'C24 of DTG and 3TC in the Fed State: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed', 'description': 'Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '0.9216', 'spread': '36.08', 'groupId': 'OG000'}, {'value': '1.1916', 'spread': '25.03', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '0.0304', 'spread': '33.07', 'groupId': 'OG000'}, {'value': '0.0366', 'spread': '35.90', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.2929', 'ciLowerLimit': '1.1281', 'ciUpperLimit': '1.4819', 'estimateComment': 'Ratio (Bfed/B) of plasma DTG has been presented', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.2015', 'ciLowerLimit': '1.1074', 'ciUpperLimit': '1.3036', 'estimateComment': 'Ratio (Bfed/B) of plasma 3TC has been presented', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.", 'unitOfMeasure': 'Micrograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter FD Summary Population'}, {'type': 'SECONDARY', 'title': 'C24 of DTG and 3TC in the Fed State: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C: DTG 50 mg and 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.'}], 'classes': [{'title': 'DTG', 'categories': [{'measurements': [{'value': '0.8355', 'spread': '38.46', 'groupId': 'OG000'}, {'value': '1.2273', 'spread': '25.73', 'groupId': 'OG001'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '0.0350', 'spread': '39.91', 'groupId': 'OG000'}, {'value': '0.0417', 'spread': '38.62', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.4690', 'ciLowerLimit': '1.3009', 'ciUpperLimit': '1.6588', 'estimateComment': 'Ratio (Cfed/C) of plasma DTG has been presented', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.1935', 'ciLowerLimit': '1.1142', 'ciUpperLimit': '1.2785', 'estimateComment': 'Ratio (Cfed/C) of plasma 3TC has been presented', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.", 'unitOfMeasure': 'Micrograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter FD Summary Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1- A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'Part 1- B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG002', 'title': 'Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed', 'description': 'Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.'}, {'id': 'OG003', 'title': 'Part 2- A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG004', 'title': 'Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG005', 'title': 'Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.'}], 'classes': [{'title': 'DBP,4 hour,n=75,76,16,75,75,16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '5.85', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '5.24', 'groupId': 'OG001'}, {'value': '-2.1', 'spread': '4.19', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '4.09', 'groupId': 'OG003'}, {'value': '-0.3', 'spread': '5.71', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '4.86', 'groupId': 'OG005'}]}]}, {'title': 'DBP,Day 2,n=74,75,16,75,75,16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '5.53', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '6.14', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '5.32', 'groupId': 'OG002'}, {'value': '-1.7', 'spread': '4.87', 'groupId': 'OG003'}, {'value': '-1.1', 'spread': '4.99', 'groupId': 'OG004'}, {'value': '3.1', 'spread': '5.37', 'groupId': 'OG005'}]}]}, {'title': 'DBP,Day 3,n=74,75,16,75,75,16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '6.83', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '5.95', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '5.19', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '5.74', 'groupId': 'OG003'}, {'value': '1.2', 'spread': '6.09', 'groupId': 'OG004'}, {'value': '3.4', 'spread': '5.76', 'groupId': 'OG005'}]}]}, {'title': 'DBP,Day 4,n=73,75,16,75,75,16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '7.4', 'spread': '6.47', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '6.64', 'groupId': 'OG001'}, {'value': '6.1', 'spread': '4.22', 'groupId': 'OG002'}, {'value': '4.9', 'spread': '6.51', 'groupId': 'OG003'}, {'value': '5.3', 'spread': '6.11', 'groupId': 'OG004'}, {'value': '8.3', 'spread': '6.94', 'groupId': 'OG005'}]}]}, {'title': 'SBP,4 hour,n=75,76,16,75,75,16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '6.12', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '5.94', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '5.49', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '5.04', 'groupId': 'OG003'}, {'value': '0.5', 'spread': '7.21', 'groupId': 'OG004'}, {'value': '1.0', 'spread': '7.28', 'groupId': 'OG005'}]}]}, {'title': 'SBP,Day 2,n=74,75,16,75,75,16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '6.88', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '6.05', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '3.91', 'groupId': 'OG002'}, {'value': '-1.5', 'spread': '5.10', 'groupId': 'OG003'}, {'value': '-1.7', 'spread': '7.12', 'groupId': 'OG004'}, {'value': '1.9', 'spread': '8.06', 'groupId': 'OG005'}]}]}, {'title': 'SBP,Day 3,n=74,75,16,75,75,16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '6.67', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '6.15', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '4.84', 'groupId': 'OG002'}, {'value': '1.9', 'spread': '7.28', 'groupId': 'OG003'}, {'value': '1.6', 'spread': '7.50', 'groupId': 'OG004'}, {'value': '2.3', 'spread': '7.73', 'groupId': 'OG005'}]}]}, {'title': 'SBP,Day 4,n=73,75,16,75,75,16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '8.2', 'spread': '8.09', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '8.43', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '5.80', 'groupId': 'OG002'}, {'value': '7.0', 'spread': '8.86', 'groupId': 'OG003'}, {'value': '7.2', 'spread': '8.72', 'groupId': 'OG004'}, {'value': '7.6', 'spread': '8.42', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 31 in Part 1 and Part 2', 'description': "SBP and DBP were measured in the supine or semi-supine position after 5 minutes rest. The Baseline value was considered to be the participant's last available assessment prior to time of the first dose. Change from Baseline was defined as post dose visit value minus Baseline value. Data for SBP and DBP for Part 1 and 2 is presented.", 'unitOfMeasure': 'Millimeters of mercury', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug. Only those participants available at the specified time points were analyzed represented by n=X,X,X,X,X,X in the category titles.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Heart Rate (HR): Part 1 and 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1- A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'Part 1- B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG002', 'title': 'Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed', 'description': 'Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.'}, {'id': 'OG003', 'title': 'Part 2- A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG004', 'title': 'Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG005', 'title': 'Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.'}], 'classes': [{'title': '4 hour,n=75,76,16,75,75,16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '5.49', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '4.25', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '3.84', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '5.25', 'groupId': 'OG003'}, {'value': '-0.3', 'spread': '5.43', 'groupId': 'OG004'}, {'value': '3.0', 'spread': '3.22', 'groupId': 'OG005'}]}]}, {'title': 'Day 2,n=74,75,16,75,75,16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '5.53', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '4.60', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '4.17', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '5.48', 'groupId': 'OG003'}, {'value': '0.6', 'spread': '5.74', 'groupId': 'OG004'}, {'value': '1.6', 'spread': '5.44', 'groupId': 'OG005'}]}]}, {'title': 'Day 3,n=74,75,16,75,75,16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '8.15', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '6.35', 'groupId': 'OG001'}, {'value': '5.8', 'spread': '6.80', 'groupId': 'OG002'}, {'value': '5.3', 'spread': '7.23', 'groupId': 'OG003'}, {'value': '3.8', 'spread': '7.13', 'groupId': 'OG004'}, {'value': '7.7', 'spread': '10.42', 'groupId': 'OG005'}]}]}, {'title': 'Day 4,n=73,75,16,75,75,16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': '9.28', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '7.68', 'groupId': 'OG001'}, {'value': '9.6', 'spread': '9.15', 'groupId': 'OG002'}, {'value': '8.9', 'spread': '8.31', 'groupId': 'OG003'}, {'value': '6.1', 'spread': '8.39', 'groupId': 'OG004'}, {'value': '9.5', 'spread': '10.10', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 31 in Part 1 and Part 2', 'description': "HR was measured in the supine or semi-supine position after 5 minutes rest. The Baseline value was considered to be the participant's last available assessment prior to time of the first dose. Change from Baseline was defined as post dose visit value minus Baseline value. Data for HR for Part 1 and 2 is presented.", 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants available at the specified time points were analyzed represented by n=X,X,X,X,X,X in the category titles.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1- A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG001', 'title': 'Part 1- B: DTG 50 mg/ 3TC 300 mg Monolayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG002', 'title': 'Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed', 'description': 'Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.'}, {'id': 'OG003', 'title': 'Part 2- A: DTG 50 mg + EPIVIR 300 mg', 'description': 'Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG004', 'title': 'Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.'}, {'id': 'OG005', 'title': 'Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed', 'description': 'Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 11', 'description': 'An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Participants having any AE or SAE are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1:DTG+EPIVIR/DTG+3TC Monolayer/DTG+3TC Monolayer-fed', 'description': 'Participants were randomized to receive dolutegravir (DTG) 50 milligram (mg) tablet plus a single lamivudine (3TC) tablet in Period 1 followed by DTG 50 mg/3TC 300 mg fixed dose combination (FDC) monolayer formulation in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC monolayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods.'}, {'id': 'FG001', 'title': 'Part 1:DTG+3TC Monolayer/DTG+EPIVIR/DTG+3TC Monolayer-fed', 'description': 'Participants were randomized to receive DTG 50 mg/3TC 300 mg FDC monolayer formulation in Period 1 followed by DTG 50 mg tablet plus a single 3TC tablet in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC monolayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods.'}, {'id': 'FG002', 'title': 'Part 2:DTG+EPIVIR/DTG+3TC Bilayer/DTG+3TC Bilayer-fed', 'description': 'Participants were randomized to receive DTG 50 mg tablet plus a single 3TC tablet in Period 1 followed by DTG 50 mg/3TC 300 mg FDC bilayer formulation in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC bilayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods.'}, {'id': 'FG003', 'title': 'Part 2:DTG+3TC Bilayer/DTG+EPIVIR /DTG+3TC Bilayer-fed', 'description': 'Participants were randomized to receive DTG 50 mg/3TC 300 mg FDC bilayer formulation in Period 1 followed by DTG 50 mg tablet plus a single 3TC tablet in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC bilayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods.'}], 'periods': [{'title': 'Treatment Period 1 (4 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 1 (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2 (4 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 2 (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'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 3 (4 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'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': 'The study was conducted in 2 parts (Part 1 and Part 2) at a single center in the United States from 27-March-2017 to 18-August-2017 and 154 participants (78 in Part 1 and 76 in Part 2) were randomized. First 16 participants completing the first 2 dosing periods, returned for a 3rd treatment period and received single dose of FDC with high fat meal', 'preAssignmentDetails': 'A total of 283 (Part 1: 150, Part 2: 133) participants were screened for this study; 125 (Part 1: 72, Part2: 53) participants were screen failures (SF) and 4 participants were reserved but not used. The reasons for SF: inclusion/exclusion criteria not met (105), withdrew consent (18), physician decision (2).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1', 'description': 'Participants were randomized into treatment sequence A/B (treatment A in Period 1 followed by B in Period 2) or B/A (treatment B in Period 1 followed by A in Period 2), where A=dolutegravir (DTG) 50 milligram (mg) tablet plus a single lamivudine (3TC) tablet and treatment B= DTG 50 mg/3TC 300 mg fixed dose combination (FDC) monolayer formulation. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC monolayer tablet formulation administered with a high fat meal in Period 3. There was a washout period of at least 7 days between each treatment period. In treatment periods 1 and 2, single dose of the treatments were administered in the fasted state.'}, {'id': 'BG001', 'title': 'Part 2', 'description': 'Participants were randomized into treatment sequence A/C (treatment A in Period 1 followed by C in Period 2) or C/A (treatment C in Period 1 followed by A in Period 2), where A=DTG 50 mg tablet plus a single 3TC tablet and treatment C= DTG 50 mg/3TC 300 mg FDC bilayer formulation. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC bilayer tablet formulation administered with a high fat meal in Period 3. There was a washout period of at least 7 days between each treatment period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.4', 'spread': '9.37', 'groupId': 'BG000'}, {'value': '31.6', 'spread': '11.18', 'groupId': 'BG001'}, {'value': '30.5', 'spread': '10.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Asian- Central/South Asian Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Asian- East Asian Heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian- South East Asian Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'White-White/Caucasian/European Heritage', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Population: All participants who enrolled in the study and received at least one dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-07', 'size': 762433, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-04-02T05:54', 'hasProtocol': True}, {'date': '2017-08-28', 'size': 871228, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-06-21T02:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-10', 'studyFirstSubmitDate': '2017-03-08', 'resultsFirstSubmitDate': '2018-08-10', 'studyFirstSubmitQcDate': '2017-03-08', 'lastUpdatePostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-10', 'studyFirstPostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity [AUC (0-Inf)] of Plasma DTG and 3TC in the Fasted State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the pharmacokinetic (PK) profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1."}, {'measure': 'AUC (0-Inf) of Plasma DTG and 3TC in the Fasted State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at given time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted conditions in Periods 1 and 2 of Part 2."}, {'measure': 'Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Time Point (AUC[0-t]) of Plasma DTG and 3TC in the Fasted State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1."}, {'measure': 'AUC(0-t) of Plasma DTG and 3TC in the Fasted State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2."}, {'measure': 'Maximum Observed Concentration (Cmax) of Plasma DTG and 3TC in the Fasted State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1."}, {'measure': 'Cmax of Plasma DTG and 3TC in the Fasted State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2."}], 'secondaryOutcomes': [{'measure': 'Absorption Lag Time (Tlag) of DTG and 3TC in Fasted State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1."}, {'measure': 'Tlag of DTG and 3TC in Fasted State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2."}, {'measure': 'Time to Reach Maximum Plasma Concentration (Tmax) of DTG and 3TC in the Fasted State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1."}, {'measure': 'Tmax of DTG and 3TC in the Fasted State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2"}, {'measure': 'Time of the Last Quantifiable Concentration (Tlast) of DTG and 3TC in the Fasted State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1."}, {'measure': 'Tlast of DTG and 3TC in the Fasted State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2"}, {'measure': 'Time to Reach Half the Maximum Plasma Concentration (t1/2) of DTG and 3TC in the Fasted State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1."}, {'measure': 't1/2 of DTG and 3TC in the Fasted State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2"}, {'measure': 'Apparent Elimination Rate Constant (Lambda z) of DTG and 3TC in the Fasted State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1."}, {'measure': 'Lambda z of DTG and 3TC in in the Fasted State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2."}, {'measure': 'Percentage of Extrapolated AUC (0 to Inf) of DTG and 3TC in the Fasted State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1."}, {'measure': 'Percentage of Extrapolated AUC(0 to Inf) of DTG and 3TC in the Fasted State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2."}, {'measure': 'AUC of 0 to 24 Hours (AUC[0-24]) of DTG and 3TC in the Fasted State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1."}, {'measure': 'AUC(0-24) of DTG and 3TC in the Fasted State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2."}, {'measure': 'Apparent Oral Clearance (CL/F) of DTG and 3TC in the Fasted State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1."}, {'measure': 'CL/F of DTG and 3TC in the Fasted State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2."}, {'measure': 'Apparent Oral Volume of Distribution (Vz/F) of DTG and 3TC in the Fasted State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1."}, {'measure': 'Vz/F of DTG and 3TC in the Fasted State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2."}, {'measure': 'Concentration at 24 Hours Post-dose (C24) of DTG and 3TC in the Fasted State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1."}, {'measure': 'C24 of DTG and 3TC in the Fasted State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2."}, {'measure': 'Last Quantifiable Concentration (Clast) of DTG and 3TC in the Fasted State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1."}, {'measure': 'Clast of DTG and 3TC in the Fasted State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2."}, {'measure': 'AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1."}, {'measure': 'AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2."}, {'measure': 'AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1."}, {'measure': 'AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2."}, {'measure': 'Cmax of Plasma DTG and 3TC in the Fed State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1."}, {'measure': 'Cmax of Plasma DTG and 3TC in the Fed State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2."}, {'measure': 'Tlag of DTG and 3TC in Fed State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1."}, {'measure': 'Tlag of DTG and 3TC in Fed State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2."}, {'measure': 'Tmax of DTG and 3TC in the Fed State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1."}, {'measure': 'Tmax of DTG and 3TC in the Fed State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2."}, {'measure': 'T1/2 of DTG and 3TC in the Fed State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1."}, {'measure': 'T1/2 of DTG and 3TC in the Fed State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2."}, {'measure': 'Lambda z of DTG and 3TC in in the Fed State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1."}, {'measure': 'Lambda z of DTG and 3TC in in the Fed State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2."}, {'measure': 'Clast of DTG and 3TC in in the Fed State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1."}, {'measure': 'Clast of DTG and 3TC in in the Fed State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2."}, {'measure': 'Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1."}, {'measure': 'Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2."}, {'measure': 'AUC(0-24) of DTG and 3TC in the Fed State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1."}, {'measure': 'AUC(0-24) of DTG and 3TC in the Fed State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2."}, {'measure': 'CL/F of DTG and 3TC in the Fed State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1."}, {'measure': 'CL/F of DTG and 3TC in the Fed State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2."}, {'measure': 'Tlast of DTG and 3TC in the Fed State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1."}, {'measure': 'Tlast of DTG and 3TC in the Fed State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2."}, {'measure': 'Vz/F of DTG and 3TC in the Fed State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1."}, {'measure': 'Vz/F of DTG and 3TC in the Fed State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2."}, {'measure': 'C24 of DTG and 3TC in the Fed State: Part 1', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1."}, {'measure': 'C24 of DTG and 3TC in the Fed State: Part 2', 'timeFrame': 'Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose', 'description': "Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2."}, {'measure': 'Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2', 'timeFrame': 'Up to Day 31 in Part 1 and Part 2', 'description': "SBP and DBP were measured in the supine or semi-supine position after 5 minutes rest. The Baseline value was considered to be the participant's last available assessment prior to time of the first dose. Change from Baseline was defined as post dose visit value minus Baseline value. Data for SBP and DBP for Part 1 and 2 is presented."}, {'measure': 'Change From Baseline in Heart Rate (HR): Part 1 and 2', 'timeFrame': 'Up to Day 31 in Part 1 and Part 2', 'description': "HR was measured in the supine or semi-supine position after 5 minutes rest. The Baseline value was considered to be the participant's last available assessment prior to time of the first dose. Change from Baseline was defined as post dose visit value minus Baseline value. Data for HR for Part 1 and 2 is presented."}, {'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2', 'timeFrame': 'Up to Week 11', 'description': 'An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Participants having any AE or SAE are presented.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FDC', 'Lamivudine', 'Bio-equivalence', 'Dolutegravir', 'HIV'], 'conditions': ['Infection, Human Immunodeficiency Virus']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the bioequivalence of two experimental fixed dose combination (FDC) tablets versus single entity products of dolutegravir (DTG) and lamivudine (3TC) in healthy adult subjects. The study will be carried out in two parts. Part 1 of the study will be open label, up to 3 periods design with a wash out period of at least 7 days between treatment periods. Subjects will be randomized to receive either single entities or formulation 1 FDC of DTG and 3TC in a crossover manner in first 2 periods. The first 16 subjects who complete the first two treatment periods and consent to continue will receive a single dose of FDC formulation 1 tablet administered with a high fat meal for a third treatment period. In Part 2 of the study, subjects will be randomized to receive either single entities or formulation 2 FDC of DTG and 3TC in a crossover manner in first 2 periods. Similarly the first 16 subjects will then receive FDC formulation 2 tablets with high fat meal in treatment period 3. Subjects will have a follow-up visit within 7-14 days after the last dose of study drug. Approximately 76 healthy subjects will be included in Part 1 of the study and if Part 2 of the study is conducted, another 76 healthy subjects will be included. The total duration will be approximately 11 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Between 18 and 55 years of age inclusive, at the time of signing the informed consent.\n* Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac evaluation (history, electrocardiogram \\[ECG\\]).\n* A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.\n* Subject must be able to swallow 2 tablets at the same time (Reference tablets only).\n* Body weight \\>=50 kilogram (kg) for men and \\>=45 kg for women and body mass index (BMI) within the range 18.5-31.0 kg per meter square (kg/m\\^2).\n* Male or Female. Female subject: is eligible to participate if she is not pregnant (as confirmed by a negative serum or urine human chorionic gonadotrophin \\[hCG\\] test), not lactating, and at least one of the following conditions applies: 1. non-reproductive potential defined as: pre-menopausal females with one of the following: documented tubal ligation; documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; documented bilateral Oophorectomy. Postmenopausal defined as 12 months of spontaneous amenorrhea; in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. 2. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication and until at least five terminal half-lives OR until any continuing pharmacologic effect has ended, whichever is longer after the last dose of study medication and completion of the follow-up visit.\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions.\n\nExclusion Criteria:\n\n* Alanine aminotransferase (ALT) and bilirubin \\>1.5x upper limit of normal (ULN) (isolated bilirubin \\>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \\<35 percentage).\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* QT interval corrected for heart rate according to Fridericia's formula (QTcF) \\> 450 milliseconds (msec).\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 medication, unless in the opinion of the Investigator and ViiV Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.\n* History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of \\>14 drinks for males or \\>7 drinks for females. One drink is equivalent to 12 gram (g) of alcohol: 12 ounces \\[360 milliliter (mL)\\] of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.\n* Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 1 month prior to screening.\n* History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.\n* Creatinine clearance (CrCL) \\<90 mL/minute.\n* A positive hepatitis B surface antigen (HBsAg) or a positive hepatitis B core antibody with a negative hepatitis B surface antibody, positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n* A positive pre-study drug/alcohol screen.\n* A positive test for HIV antibody.\n* Where participation in the study would result in donation of blood or blood product in excess of 500 mL within 56 days.\n* The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).\n* Exposure to more than four new chemical entities within 12 months prior to the first dosing day."}, 'identificationModule': {'nctId': 'NCT03078556', 'briefTitle': 'Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'An Open-label, Randomized, Single Dose, Crossover, Pivotal Bioequivalence Study of Fixed-dose Combination Tablets of Dolutegravir and Lamivudine Versus Dolutegravir and Lamivudine Single Entities and Food Effect Assessment in Healthy Volunteers', 'orgStudyIdInfo': {'id': '204994'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment sequence A/B: Part 1', 'description': 'Eligible subjects will be randomized in sequence A/B and will receive A: DTG 50 milligram (mg) and 3TC 300 mg single entities in Period 1, B: DTG 3TC FDC formulation 1 tablet in Period 2.', 'interventionNames': ['Drug: Dolutegravir', 'Drug: Lamivudine', 'Drug: Dolutegravir + Lamivudine FDC Formulation 1']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment sequence B/A: Part 1', 'description': 'Eligible subjects will be randomized in sequence B/A and will receive B: DTG 3TC FDC formulation 1 tablet in Period 1 and A: DTG 50 mg and 3TC 300 mg single entities in Period 2.', 'interventionNames': ['Drug: Dolutegravir', 'Drug: Lamivudine', 'Drug: Dolutegravir + Lamivudine FDC Formulation 1']}, {'type': 'EXPERIMENTAL', 'label': 'Subjects receiving high fat meal: Part 1', 'description': 'Eligible subjects will be administered single dose of DTG 3TC FDC formulation 1 tablet with high fat meal in Period 3 to study the effect of food on tablet.', 'interventionNames': ['Drug: Dolutegravir + Lamivudine FDC Formulation 1']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment sequence A/C: Part 2', 'description': 'Eligible subjects will be randomized in sequence A/B and will receive A: DTG 50 mg and 3TC 300 mg single entities in Period 1 and C: DTG 3TC FDC formulation 2 tablet in Period 2.', 'interventionNames': ['Drug: Dolutegravir', 'Drug: Lamivudine', 'Drug: Dolutegravir + Lamivudine FDC Formulation 2']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment sequence C/A: Part 2', 'description': 'Eligible subjects will be randomized in sequence C/A and will receive C: DTG 3TC FDC formulation 2 tablet in Period 1 and A: DTG 50 milligram (mg) and 3TC 300 mg single entities in Period 2.', 'interventionNames': ['Drug: Dolutegravir', 'Drug: Lamivudine', 'Drug: Dolutegravir + Lamivudine FDC Formulation 2']}, {'type': 'EXPERIMENTAL', 'label': 'Subjects receiving high fat meal: Part 2', 'description': 'Eligible subjects will be administered single dose of DTG 3TC FDC formulation 2 tablet with high fat meal in Period 3 to study the effect of food on tablet.', 'interventionNames': ['Drug: Dolutegravir + Lamivudine FDC Formulation 2']}], 'interventions': [{'name': 'Dolutegravir', 'type': 'DRUG', 'description': 'Single dose of DTG 50 mg tablet along with 3TC (EPIVIR) tablet will be given to randomized subjects in parts 1 and 2 with 240 mL of room temperature water. DTG will be a white, film coated, round tablet engraved with SV 572 on one side and 50 on the other side.', 'armGroupLabels': ['Treatment sequence A/B: Part 1', 'Treatment sequence A/C: Part 2', 'Treatment sequence B/A: Part 1', 'Treatment sequence C/A: Part 2']}, {'name': 'Lamivudine', 'type': 'DRUG', 'description': 'Single dose 3TC (commercial name: EPIVIR) 300 mg tablet along with DTG tablet will be given to randomized subjects in parts 1 and 2 with 240 mL of room temperature water.\\<br\\>3TC will be gray, diamond shaped tablet, engraved "GX EJ7" on one side and plain on the other side.', 'armGroupLabels': ['Treatment sequence A/B: Part 1', 'Treatment sequence A/C: Part 2', 'Treatment sequence B/A: Part 1', 'Treatment sequence C/A: Part 2']}, {'name': 'Dolutegravir + Lamivudine FDC Formulation 1', 'type': 'DRUG', 'description': "Single dose of DTG 50 mg combined with 3TC 300 mg in a FDC formulation 1 tablet will be administered to randomized subjects in treatment periods 1 and 2 (under fasted state) of Part 1 and the first 16 subjects in treatment period 3 (under fed) of Part 1 with 240 mL of room temperature water. \\<br\\>FDC formulation 1 tablets will be oval, biconvex, white, film coated tablet engraved 'SV H7I' on one face.", 'armGroupLabels': ['Subjects receiving high fat meal: Part 1', 'Treatment sequence A/B: Part 1', 'Treatment sequence B/A: Part 1']}, {'name': 'Dolutegravir + Lamivudine FDC Formulation 2', 'type': 'DRUG', 'description': "Single dose of DTG 50 mg combined with 3TC 300 mg in a FDC formulation 2 tablet will be administered to randomized subjects in treatment periods 1 and 2 (under fasted state) and the first 16 subjects in treatment period 3 (under fed) of Part 2 with 240 mL of room temperature water. \\<br\\>FDC formulation 2 tablets will be oval, biconvex, white, film coated tablet engraved 'SV 13N' on one face.", 'armGroupLabels': ['Subjects receiving high fat meal: Part 2', 'Treatment sequence A/C: Part 2', 'Treatment sequence C/A: Part 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ViiV Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}