Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-26 @ 7:05 AM
Study NCT ID:
NCT06201559
Status:
COMPLETED
Last Update Posted:
2025-01-27
First Post:
2023-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioequivalence Study Between Two Albendazole 400 mg Tablets in Healthy Adult Participants Under Fed Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007410', 'term': 'Intestinal Diseases'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015766', 'term': 'Albendazole'}], 'ancestors': [{'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected through the entire study duration of up to a maximum of 22 days.', 'description': 'Safety Population included all randomized participants who received at least 1 dose of study medication. Each participant was counted once throughout the study for this analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Albendazole IP 400mg- Test (T)', 'description': 'Participants received a single oral dose of 400 mg Albendazole Indian Pharmacopoeia (IP) tablet under fed conditions on Day 1 in either treatment Periods 1, 2, 3 and 4.', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 6, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Albendazole 400mg- Reference (R)', 'description': 'Participants received a single oral dose of 400 mg Albendazole tablet under fed conditions on Day 1 in either treatment Periods 1, 2, 3 and 4.', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 6, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) of Albendazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Albendazole IP 400 mg/400mg - Test 1 (T1)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4.'}, {'id': 'OG001', 'title': 'Albendazole IP 400 mg/400 mg - Test 2 (T2)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4.'}, {'id': 'OG002', 'title': 'Albendazole 400 mg/IP 400 mg - Reference 1 (R1)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4.'}, {'id': 'OG003', 'title': 'Albendazole 400 mg/IP 400 mg - Reference 2 (R2)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.846', 'spread': '114.1', 'groupId': 'OG000'}, {'value': '41.685', 'spread': '110.9', 'groupId': 'OG001'}, {'value': '39.737', 'spread': '112.1', 'groupId': 'OG002'}, {'value': '46.115', 'spread': '102.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Ratio of Geometric Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '98.1', 'ciLowerLimit': '86.79', 'ciUpperLimit': '110.91', 'estimateComment': 'Geometric least square means were combined to perform statistical analysis of T as T1 + T2 and R as R1 + R2.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Point estimate of geometric mean ratio (GMR) of T/R should be between 80.00 -125.00%. If the intra-subject variability for Cmax following replicate administrations of the comparator product was \\> 30%, the acceptance criteria for Cmax was widened to a maximum of 69.84-143.19%.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours', 'description': 'Blood samples were collected for pharmacokinetic (PK) analysis of Albendazole. PK parameter was determined using standard non-compartmental methods.', 'unitOfMeasure': 'nanogram/millilitre (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included all participants in Safety set who had at least 1 measurable PK assessment. As pre-specified in Statistical Analysis Plan (SAP), data is collected and reported for PK parameters per study intervention i.e. Test Study Intervention-T1 (1st administration), Test Study Intervention-T2 (2nd administration), and Reference Study Intervention-R1 and Reference Study Intervention-R2 similarly. Only those participants with data available at specified time points have been analyzed.'}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] for Albendazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Albendazole IP 400 mg/400mg - Test 1 (T1)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG001', 'title': 'Albendazole IP 400 mg/400mg - Test 2 (T2)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG002', 'title': 'Albendazole 400 mg/ IP 400mg - Reference 1 (R1)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG003', 'title': 'Albendazole 400 mg/ IP 400mg - Reference 2 (R2)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}], 'classes': [{'categories': [{'measurements': [{'value': '179.419', 'spread': '129.5', 'groupId': 'OG000'}, {'value': '164.052', 'spread': '120.4', 'groupId': 'OG001'}, {'value': '161.034', 'spread': '127.4', 'groupId': 'OG002'}, {'value': '182.792', 'spread': '117.2', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Ratio of Geometric Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '97.6', 'ciLowerLimit': '86.86', 'ciUpperLimit': '109.73', 'estimateComment': 'Geometric least square means were combined to perform statistical analysis of T as T1 + T2 and R as R1 + R2.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Point estimate of geometric mean ratio (GMR) of T/R should be between 80.00 -125.00%. If the intra-subject variability for AUC(0-t) following replicate administrations of the comparator product was \\> 30%, the acceptance criteria for AUC(0-t) was widened to a maximum of 69.84-143.19%.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours', 'description': 'Blood samples were collected for PK analysis of Albendazole. PK parameter was determined using standard non-compartmental methods.', 'unitOfMeasure': 'Nanogram*hour/ milliliter (ng*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. As pre-specified in the Statistical Analysis Plan (SAP), data is collected and reported for PK parameters per study intervention i.e. Test Study Intervention-T1 (1st administration), Test Study Intervention-T2 (2nd administration), Reference Study Intervention-R1 (1st administration) and Reference Study Intervention-R2 (2nd administration). Only those participants with data available at specified time points have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration (Cmax) of Albendazole Sulfoxide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Albendazole IP 400 mg/ 400mg - Test 1 (T1)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG001', 'title': 'Albendazole IP 400 mg/ 400mg - Test 2 (T2)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG002', 'title': 'Albendazole 400 mg/ IP 400mg - Reference 1 (R1)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG003', 'title': 'Albendazole 400 mg/ IP 400mg - Reference 2 (R2)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}], 'classes': [{'categories': [{'measurements': [{'value': '638.051', 'spread': '63.3', 'groupId': 'OG000'}, {'value': '644.730', 'spread': '59.4', 'groupId': 'OG001'}, {'value': '643.276', 'spread': '62.6', 'groupId': 'OG002'}, {'value': '710.382', 'spread': '53.8', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours', 'description': 'Blood samples were collected for PK analysis of Albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. As pre-specified in the Statistical Analysis Plan (SAP), data is collected and reported for PK parameters per study intervention i.e. Test Study Intervention-T1 (1st administration), Test Study Intervention-T2 (2nd administration), Reference Study Intervention-R1 (1st administration) and Reference Study Intervention-R2 (2nd administration). Only those participants with data available at specified time points have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] of Albendazole Sulfoxide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Albendazole IP 400 mg/ 400mg - Test 1 (T1)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG001', 'title': 'Albendazole IP 400 mg/ 400mg - Test 2 (T2)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG002', 'title': 'Albendazole 400 mg/ IP 400mg - Reference 1 (R1)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG003', 'title': 'Albendazole 400 mg/ IP 400mg - Reference 2 (R2)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}], 'classes': [{'categories': [{'measurements': [{'value': '6129.744', 'spread': '74.2', 'groupId': 'OG000'}, {'value': '6023.449', 'spread': '68.9', 'groupId': 'OG001'}, {'value': '6046.054', 'spread': '73.2', 'groupId': 'OG002'}, {'value': '6572.338', 'spread': '67.8', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours', 'description': 'Blood samples were collected for PK analysis of Albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. As pre-specified in the Statistical Analysis Plan (SAP), data is collected and reported for PK parameters per study intervention i.e. Test Study Intervention-T1 (1st administration), Test Study Intervention-T2 (2nd administration), Reference Study Intervention-R1 (1st administration) and Reference Study Intervention-R2 (2nd administration). Only those participants with data available at specified time points have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve Extrapolated to Infinity [AUC0-inf] of Albendazole and Albendazole Sulfoxide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Albendazole IP 400 mg/ 400 mg - Test 1 (T1)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG001', 'title': 'Albendazole IP 400 mg/ 400 mg - Test 2 (T2)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG002', 'title': 'Albendazole 400 mg / IP 400mg- Reference 1 (R1)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG003', 'title': 'Albendazole 400 mg/ IP 400mg - Reference 2 (R2)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}], 'classes': [{'title': 'Albendazole', 'categories': [{'measurements': [{'value': '189.347', 'spread': '128.6', 'groupId': 'OG000'}, {'value': '174.979', 'spread': '119.0', 'groupId': 'OG001'}, {'value': '169.433', 'spread': '127.1', 'groupId': 'OG002'}, {'value': '192.388', 'spread': '116.1', 'groupId': 'OG003'}]}]}, {'title': 'Albendazole sulfoxide', 'categories': [{'measurements': [{'value': '7372.856', 'spread': '80.1', 'groupId': 'OG000'}, {'value': '7189.644', 'spread': '73.4', 'groupId': 'OG001'}, {'value': '7204.107', 'spread': '81.2', 'groupId': 'OG002'}, {'value': '7816.474', 'spread': '74.5', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours', 'description': 'Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. As pre-specified in the Statistical Analysis Plan (SAP), data is collected and reported for PK parameters per study intervention i.e. Test Study Intervention-T1 (1st administration), Test Study Intervention-T2 (2nd administration), Reference Study Intervention-R1 (1st administration) and Reference Study Intervention-R2 (2nd administration). Only those participants with data available at specified time points have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Time Until Cmax is Reached (Tmax) for Albendazole and Albendazole Sulfoxide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Albendazole IP 400 mg/ 400 mg - Test 1 (T1)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG001', 'title': 'Albendazole IP 400 mg/ 400 mg - Test 2 (T2)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG002', 'title': 'Albendazole 400 mg / IP 400mg- Reference 1 (R1)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG003', 'title': 'Albendazole 400 mg/ IP 400mg - Reference 2 (R2)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}], 'classes': [{'title': 'Albendazole', 'categories': [{'measurements': [{'value': '3.31', 'spread': '33.4', 'groupId': 'OG000'}, {'value': '3.41', 'spread': '30.4', 'groupId': 'OG001'}, {'value': '3.39', 'spread': '32.9', 'groupId': 'OG002'}, {'value': '3.52', 'spread': '30.6', 'groupId': 'OG003'}]}]}, {'title': 'Albendazole sulfoxide', 'categories': [{'measurements': [{'value': '4.64', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '4.64', 'spread': '21.7', 'groupId': 'OG001'}, {'value': '4.62', 'spread': '19.4', 'groupId': 'OG002'}, {'value': '4.63', 'spread': '20.0', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours', 'description': 'Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.', 'unitOfMeasure': 'hour (h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. As pre-specified in the Statistical Analysis Plan (SAP), data is collected and reported for PK parameters per study intervention i.e. Test Study Intervention-T1 (1st administration), Test Study Intervention-T2 (2nd administration), Reference Study Intervention-R1 (1st administration) and Reference Study Intervention-R2 (2nd administration). Only those participants with data available at specified time points have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration Half-life (t1/2) of Albendazole and Albendazole Sulfoxide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Albendazole IP 400 mg/ 400mg - Test 1 (T1)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG001', 'title': 'Albendazole IP 400 mg/ 400mg - Test 2 (T2)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG002', 'title': 'Albendazole 400 mg/ IP 400mg - Reference 1 (R1)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG003', 'title': 'Albendazole 400 mg/ IP 400mg - Reference 2 (R2)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}], 'classes': [{'title': 'Albendazole', 'categories': [{'measurements': [{'value': '5.22', 'spread': '55.1', 'groupId': 'OG000'}, {'value': '5.53', 'spread': '74.9', 'groupId': 'OG001'}, {'value': '5.11', 'spread': '60.0', 'groupId': 'OG002'}, {'value': '5.62', 'spread': '56.0', 'groupId': 'OG003'}]}]}, {'title': 'Albendazole sulfoxide', 'categories': [{'measurements': [{'value': '8.47', 'spread': '34.8', 'groupId': 'OG000'}, {'value': '8.20', 'spread': '28.4', 'groupId': 'OG001'}, {'value': '8.21', 'spread': '28.2', 'groupId': 'OG002'}, {'value': '8.07', 'spread': '32.8', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours', 'description': 'Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.', 'unitOfMeasure': 'hour (h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. As pre-specified in the Statistical Analysis Plan (SAP), data is collected and reported for PK parameters per study intervention i.e. Test Study Intervention-T1 (1st administration), Test Study Intervention-T2 (2nd administration), Reference Study Intervention-R1 (1st administration) and Reference Study Intervention-R2 (2nd administration). Only those participants with data available at specified time points have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Terminal Elimination Rate Constant (Lambda-z (λz)) of Albendazole and Albendazole Sulfoxide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Albendazole IP 400 mg/ 400 mg - Test 1 (T1)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG001', 'title': 'Albendazole IP 400 mg/ 400mg - Test 2 (T2)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG002', 'title': 'Albendazole 400 mg/ IP 400mg - Reference 1 (R1)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG003', 'title': 'Albendazole 400 mg/ IP 400mg - Reference 2 (R2)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}], 'classes': [{'title': 'Albendazole', 'categories': [{'measurements': [{'value': '0.133', 'spread': '57.6', 'groupId': 'OG000'}, {'value': '0.125', 'spread': '61.8', 'groupId': 'OG001'}, {'value': '0.136', 'spread': '60.8', 'groupId': 'OG002'}, {'value': '0.123', 'spread': '43.8', 'groupId': 'OG003'}]}]}, {'title': 'Albendazole sulfoxide', 'categories': [{'measurements': [{'value': '0.082', 'spread': '29.3', 'groupId': 'OG000'}, {'value': '0.085', 'spread': '40.7', 'groupId': 'OG001'}, {'value': '0.084', 'spread': '33.0', 'groupId': 'OG002'}, {'value': '0.086', 'spread': '38.9', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours', 'description': 'Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.', 'unitOfMeasure': '1/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. As pre-specified in the Statistical Analysis Plan (SAP), data is collected and reported for PK parameters per study intervention i.e. Test Study Intervention-T1 (1st administration), Test Study Intervention-T2 (2nd administration), Reference Study Intervention-R1 (1st administration) and Reference Study Intervention-R2 (2nd administration). Only those participants with data available at specified time points have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Observed Percentage of Extrapolated Area Under Concentration (AUC_% Extrap_obs) for Albendazole and Albendazole Sulfoxide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Albendazole IP 400 mg / 400mg- Test 1 (T1)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG001', 'title': 'Albendazole IP 400 mg/ 400mg - Test 2 (T2)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG002', 'title': 'Albendazole 400 mg/ IP 400mg - Reference 1 (R1)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}, {'id': 'OG003', 'title': 'Albendazole 400 mg/ IP 400mg - Reference 2 (R2)', 'description': 'Participants were orally administered with Albendazole (400 mg or 400 mg IP) tablet as single dose treatment under fed conditions on Day 1 in Periods 1, 2, 3 and 4'}], 'classes': [{'title': 'Albendazole', 'categories': [{'measurements': [{'value': '3.304', 'spread': '111.2', 'groupId': 'OG000'}, {'value': '3.241', 'spread': '99.0', 'groupId': 'OG001'}, {'value': '3.763', 'spread': '112.6', 'groupId': 'OG002'}, {'value': '3.275', 'spread': '90.6', 'groupId': 'OG003'}]}]}, {'title': 'Albendazole sulfoxide', 'categories': [{'measurements': [{'value': '14.513', 'spread': '47.9', 'groupId': 'OG000'}, {'value': '13.726', 'spread': '45.7', 'groupId': 'OG001'}, {'value': '13.795', 'spread': '45.1', 'groupId': 'OG002'}, {'value': '13.243', 'spread': '50.8', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours', 'description': 'Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. As pre-specified in the Statistical Analysis Plan (SAP), data is collected and reported for PK parameters per study intervention i.e. Test Study Intervention-T1 (1st administration), Test Study Intervention-T2 (2nd administration), Reference Study Intervention-R1 (1st administration) and Reference Study Intervention-R2 (2nd administration). Only those participants with data available at specified time points have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albendazole IP 400mg- Test (T)', 'description': 'Participants received a single oral dose of 400 mg Albendazole Indian Pharmacopoeia (IP) tablet under fed conditions on Day 1 in either treatment Periods 1, 2, 3 and 4.'}, {'id': 'OG001', 'title': 'Albendazole 400mg- Reference (R)', 'description': 'Participants received a single oral dose of 400 mg Albendazole tablet under fed conditions on Day 1 in either treatment Periods 1, 2, 3 and 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 22 days', 'description': 'A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all randomized participants who received at least 1 dose of study medication. Each participant was counted once throughout the study for this analysis.'}, {'type': 'SECONDARY', 'title': 'Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TRTR', 'description': 'Participants were orally administered with 400 milligram (mg) Albendazole Indian Pharmacopoeia (IP) - (T) tablet as single dose treatment under fed conditions on Day 1 in Period 1, followed by single dose treatment of 400 mg albendazole (R) tablets in Period 2, then 400 mg single dose of albendazole (T) further followed by 400 mg single dose of albendazole (R)'}, {'id': 'OG001', 'title': 'RTRT', 'description': 'Participants were orally administered with 400 milligram (mg) Albendazole (R) tablet as single dose treatment under fed conditions on Day 1 in Period 1, followed by single dose treatment of 400 mg albendazole (T) tablets in Period 2, then 400 mg single dose of albendazole (R) further followed by 400 mg single dose of albendazole (T)'}], 'classes': [{'title': 'DBP - Period 1, Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.1', 'spread': '4.17', 'groupId': 'OG000'}, {'value': '77.1', 'spread': '4.32', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 1, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.8', 'spread': '3.47', 'groupId': 'OG000'}, {'value': '75.7', 'spread': '3.50', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 1, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.6', 'spread': '4.41', 'groupId': 'OG000'}, {'value': '75.7', 'spread': '4.29', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 1, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.4', 'spread': '5.20', 'groupId': 'OG000'}, {'value': '71.4', 'spread': '3.90', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 1, 12 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.9', 'spread': '5.22', 'groupId': 'OG000'}, {'value': '73.9', 'spread': '4.70', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 1, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.2', 'spread': '3.71', 'groupId': 'OG000'}, {'value': '75.5', 'spread': '2.83', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 2, Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.9', 'spread': '3.26', 'groupId': 'OG000'}, {'value': '75.7', 'spread': '3.38', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 2, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.4', 'spread': '5.55', 'groupId': 'OG000'}, {'value': '71.9', 'spread': '4.66', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 2, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.3', 'spread': '4.13', 'groupId': 'OG000'}, {'value': '71.5', 'spread': '4.89', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 2, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.5', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '74.2', 'spread': '2.65', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 2,12 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.7', 'spread': '5.62', 'groupId': 'OG000'}, {'value': '73.2', 'spread': '4.81', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 2, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.2', 'spread': '3.52', 'groupId': 'OG000'}, {'value': '76.7', 'spread': '4.02', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 3, Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.9', 'spread': '3.17', 'groupId': 'OG000'}, {'value': '78.9', 'spread': '3.48', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 3, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.6', 'spread': '5.56', 'groupId': 'OG000'}, {'value': '75.1', 'spread': '4.43', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 3, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.3', 'spread': '5.47', 'groupId': 'OG000'}, {'value': '73.3', 'spread': '3.93', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 3, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.1', 'spread': '6.18', 'groupId': 'OG000'}, {'value': '74.4', 'spread': '4.78', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 3,12 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.0', 'spread': '4.49', 'groupId': 'OG000'}, {'value': '73.4', 'spread': '4.05', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 3, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.9', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '75.7', 'spread': '3.94', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 4, Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.3', 'spread': '3.47', 'groupId': 'OG000'}, {'value': '76.0', 'spread': '3.68', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 4, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.5', 'spread': '4.79', 'groupId': 'OG000'}, {'value': '73.7', 'spread': '4.51', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 4, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.1', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '73.8', 'spread': '3.94', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 4, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.2', 'spread': '2.86', 'groupId': 'OG000'}, {'value': '73.8', 'spread': '3.34', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 4, 12 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.3', 'spread': '3.47', 'groupId': 'OG000'}, {'value': '74.7', 'spread': '4.31', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 4, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.1', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '75.6', 'spread': '3.12', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 1, Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116.1', 'spread': '3.53', 'groupId': 'OG000'}, {'value': '116.3', 'spread': '3.22', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 1, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116.2', 'spread': '3.46', 'groupId': 'OG000'}, {'value': '116.9', 'spread': '2.71', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 1, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116.3', 'spread': '4.51', 'groupId': 'OG000'}, {'value': '117.4', 'spread': '3.99', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 1, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '117.3', 'spread': '4.60', 'groupId': 'OG000'}, {'value': '119.5', 'spread': '5.20', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 1, 12 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116.5', 'spread': '4.90', 'groupId': 'OG000'}, {'value': '117.4', 'spread': '4.02', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 1, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116.7', 'spread': '3.29', 'groupId': 'OG000'}, {'value': '117.0', 'spread': '3.89', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 2, Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '113.9', 'spread': '4.50', 'groupId': 'OG000'}, {'value': '116.4', 'spread': '3.12', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 2, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '120.3', 'spread': '4.64', 'groupId': 'OG000'}, {'value': '119.8', 'spread': '2.89', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 2, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '119.4', 'spread': '2.55', 'groupId': 'OG000'}, {'value': '120.3', 'spread': '4.07', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 2, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '117.5', 'spread': '3.90', 'groupId': 'OG000'}, {'value': '116.8', 'spread': '4.22', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 2, 12 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '118.6', 'spread': '4.45', 'groupId': 'OG000'}, {'value': '119.6', 'spread': '4.21', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 2, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116.6', 'spread': '3.70', 'groupId': 'OG000'}, {'value': '117.0', 'spread': '4.53', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 3, Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '118.7', 'spread': '3.12', 'groupId': 'OG000'}, {'value': '117.9', 'spread': '3.73', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 3, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '114.2', 'spread': '4.14', 'groupId': 'OG000'}, {'value': '115.7', 'spread': '3.67', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 3, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '115.9', 'spread': '3.88', 'groupId': 'OG000'}, {'value': '114.8', 'spread': '3.51', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 3, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '115.0', 'spread': '4.40', 'groupId': 'OG000'}, {'value': '115.2', 'spread': '3.69', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 3, 12 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '115.4', 'spread': '3.39', 'groupId': 'OG000'}, {'value': '115.1', 'spread': '3.33', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 3, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116.8', 'spread': '3.89', 'groupId': 'OG000'}, {'value': '116.0', 'spread': '3.01', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 4, Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '117.0', 'spread': '3.18', 'groupId': 'OG000'}, {'value': '116.4', 'spread': '2.99', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 4, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116.6', 'spread': '3.20', 'groupId': 'OG000'}, {'value': '116.3', 'spread': '3.35', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 4, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116.6', 'spread': '3.91', 'groupId': 'OG000'}, {'value': '115.9', 'spread': '4.23', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 4, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '118.3', 'spread': '3.43', 'groupId': 'OG000'}, {'value': '119.1', 'spread': '3.81', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 4, 12 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116.3', 'spread': '3.69', 'groupId': 'OG000'}, {'value': '115.6', 'spread': '3.94', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 4, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116.0', 'spread': '3.13', 'groupId': 'OG000'}, {'value': '115.2', 'spread': '3.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours (Hrs) post-dose in each period', 'description': 'Diastolic blood pressure (DBP) and systolic blood pressure (SBP) were collected in sitting position.', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. As pre-specified in SAP, data for safety was collected and reported across two treatment groups as participants were randomized in either of the two treatment sequences (TRTR or RTRT) at the start of the study and they remained in the same sequence until end of the study. Each participant was counted once throughout the study for this analysis.'}, {'type': 'SECONDARY', 'title': 'Absolute Values of Vital Signs: Respiratory Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TRTR', 'description': 'Participants were orally administered with 400 milligram (mg) Albendazole Indian Pharmacopoeia (IP) - (T) tablet as single dose treatment under fed conditions on Day 1 in Period 1, followed by single dose treatment of 400 mg albendazole (R) tablets in Period 2, then 400 mg single dose of albendazole (T) further followed by 400 mg single dose of albendazole (R)'}, {'id': 'OG001', 'title': 'RTRT', 'description': 'Participants were orally administered with 400 milligram (mg) Albendazole (R) tablet as single dose treatment under fed conditions on Day 1 in Period 1, followed by single dose treatment of 400 mg albendazole (T) tablets in Period 2, then 400 mg single dose of albendazole (R) further followed by 400 mg single dose of albendazole (T)'}], 'classes': [{'title': 'At Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.5', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '2.21', 'groupId': 'OG001'}]}]}, {'title': 'Period 1, after Check-in', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.0', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '16.4', 'spread': '1.82', 'groupId': 'OG001'}]}]}, {'title': 'Period 1, before Check-out', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.5', 'spread': '2.69', 'groupId': 'OG000'}, {'value': '16.5', 'spread': '2.33', 'groupId': 'OG001'}]}]}, {'title': 'Period 2, after Check-in', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.3', 'spread': '2.72', 'groupId': 'OG000'}, {'value': '16.8', 'spread': '2.34', 'groupId': 'OG001'}]}]}, {'title': 'Period 2, before Check-out', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.6', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '16.8', 'spread': '2.64', 'groupId': 'OG001'}]}]}, {'title': 'Period 3, after Check-in', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.9', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '2.50', 'groupId': 'OG001'}]}]}, {'title': 'Period 3, before Check-out', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.0', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '16.3', 'spread': '2.06', 'groupId': 'OG001'}]}]}, {'title': 'Period 4, after Check-in', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.6', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '18.3', 'spread': '2.67', 'groupId': 'OG001'}]}]}, {'title': 'Period 4, before Check-out', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.9', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '17.7', 'spread': '2.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At screening, after check-in and before check-out in each period (each period is of 1 day)', 'description': 'Respiratory rate was collected in sitting position.', 'unitOfMeasure': 'breaths per minute (bpm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. As pre-specified in SAP, data for safety was collected and reported across two treatment groups as participants were randomized in either of the two treatment sequences (TRTR or RTRT) at the start of the study and they remained in the same sequence until end of the study. Each participant was counted once throughout the study for this analysis. Only those participants with data available in specified categories have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Absolute Values of Vital Signs: Radial Pulse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TRTR', 'description': 'Participants were orally administered with 400 milligram (mg) Albendazole Indian Pharmacopoeia (IP) - (T) tablet as single dose treatment under fed conditions on Day 1 in Period 1, followed by single dose treatment of 400 mg albendazole (R) tablets in Period 2, then 400 mg single dose of albendazole (T) further followed by 400 mg single dose of albendazole (R)'}, {'id': 'OG001', 'title': 'RTRT', 'description': 'Participants were orally administered with 400 milligram (mg) Albendazole (R) tablet as single dose treatment under fed conditions on Day 1 in Period 1, followed by single dose treatment of 400 mg albendazole (T) tablets in Period 2, then 400 mg single dose of albendazole (R) further followed by 400 mg single dose of albendazole (T)'}], 'classes': [{'title': 'Period 1, Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.9', 'spread': '6.31', 'groupId': 'OG000'}, {'value': '74.2', 'spread': '6.62', 'groupId': 'OG001'}]}]}, {'title': 'Period 1, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.6', 'spread': '3.49', 'groupId': 'OG000'}, {'value': '70.4', 'spread': '3.39', 'groupId': 'OG001'}]}]}, {'title': 'Period 1, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.4', 'spread': '4.38', 'groupId': 'OG000'}, {'value': '72.9', 'spread': '4.53', 'groupId': 'OG001'}]}]}, {'title': 'Period 1, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.8', 'spread': '3.73', 'groupId': 'OG000'}, {'value': '71.1', 'spread': '4.37', 'groupId': 'OG001'}]}]}, {'title': 'Period 1, 12 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.1', 'spread': '4.80', 'groupId': 'OG000'}, {'value': '70.7', 'spread': '3.73', 'groupId': 'OG001'}]}]}, {'title': 'Period 1, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.7', 'spread': '3.60', 'groupId': 'OG000'}, {'value': '71.4', 'spread': '3.68', 'groupId': 'OG001'}]}]}, {'title': 'Period 2, Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.4', 'spread': '3.36', 'groupId': 'OG000'}, {'value': '73.9', 'spread': '5.48', 'groupId': 'OG001'}]}]}, {'title': 'Period 2, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.4', 'spread': '4.48', 'groupId': 'OG000'}, {'value': '68.0', 'spread': '4.20', 'groupId': 'OG001'}]}]}, {'title': 'Period 2, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.9', 'spread': '3.44', 'groupId': 'OG000'}, {'value': '68.6', 'spread': '4.20', 'groupId': 'OG001'}]}]}, {'title': 'Period 2, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.8', 'spread': '5.05', 'groupId': 'OG000'}, {'value': '74.2', 'spread': '4.39', 'groupId': 'OG001'}]}]}, {'title': 'Period 2, 12 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.2', 'spread': '4.17', 'groupId': 'OG000'}, {'value': '71.7', 'spread': '5.41', 'groupId': 'OG001'}]}]}, {'title': 'Period 2, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.2', 'spread': '3.92', 'groupId': 'OG000'}, {'value': '71.0', 'spread': '3.26', 'groupId': 'OG001'}]}]}, {'title': 'Period 3, Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.6', 'spread': '4.02', 'groupId': 'OG000'}, {'value': '74.7', 'spread': '6.32', 'groupId': 'OG001'}]}]}, {'title': 'Period 3, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.6', 'spread': '5.27', 'groupId': 'OG000'}, {'value': '71.9', 'spread': '3.95', 'groupId': 'OG001'}]}]}, {'title': 'Period 3, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.8', 'spread': '5.65', 'groupId': 'OG000'}, {'value': '70.0', 'spread': '3.66', 'groupId': 'OG001'}]}]}, {'title': 'Period 3, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.7', 'spread': '5.22', 'groupId': 'OG000'}, {'value': '71.9', 'spread': '4.38', 'groupId': 'OG001'}]}]}, {'title': 'Period 3, 12 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.0', 'spread': '5.21', 'groupId': 'OG000'}, {'value': '73.1', 'spread': '3.52', 'groupId': 'OG001'}]}]}, {'title': 'Period 3, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.9', 'spread': '5.56', 'groupId': 'OG000'}, {'value': '70.6', 'spread': '4.05', 'groupId': 'OG001'}]}]}, {'title': 'Period 4, Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.0', 'spread': '6.51', 'groupId': 'OG000'}, {'value': '75.3', 'spread': '7.10', 'groupId': 'OG001'}]}]}, {'title': 'Period 4, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.6', 'spread': '5.04', 'groupId': 'OG000'}, {'value': '68.8', 'spread': '3.99', 'groupId': 'OG001'}]}]}, {'title': 'Period 4, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.2', 'spread': '2.85', 'groupId': 'OG000'}, {'value': '71.4', 'spread': '4.17', 'groupId': 'OG001'}]}]}, {'title': 'Period 4, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.2', 'spread': '2.98', 'groupId': 'OG000'}, {'value': '72.0', 'spread': '2.52', 'groupId': 'OG001'}]}]}, {'title': 'Period 4, 12 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.6', 'spread': '3.19', 'groupId': 'OG000'}, {'value': '72.9', 'spread': '3.10', 'groupId': 'OG001'}]}]}, {'title': 'Period 4, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.9', 'spread': '4.71', 'groupId': 'OG000'}, {'value': '71.5', 'spread': '5.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period (each period is of 1 day)', 'description': 'Radial pulse was collected in sitting position.', 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. As pre-specified in SAP, data for safety was collected and reported across two treatment groups as participants were randomized in either of the two treatment sequences (TRTR or RTRT) at the start of the study and they remained in the same sequence until end of the study. Each participant was counted once throughout the study for this analysis. Only those participants with data available in specified categories have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Signs: Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TRTR', 'description': 'Participants were orally administered with 400 milligram (mg) Albendazole Indian Pharmacopoeia (IP) - (T) tablet as single dose treatment under fed conditions on Day 1 in Period 1, followed by single dose treatment of 400 mg albendazole (R) tablets in Period 2, then 400 mg single dose of albendazole (T) further followed by 400 mg single dose of albendazole (R)'}, {'id': 'OG001', 'title': 'RTRT', 'description': 'Participants were orally administered with 400 milligram (mg) Albendazole (R) tablet as single dose treatment under fed conditions on Day 1 in Period 1, followed by single dose treatment of 400 mg albendazole (T) tablets in Period 2, then 400 mg single dose of albendazole (R) further followed by 400 mg single dose of albendazole (T)'}], 'classes': [{'title': 'DBP - Period 1, Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 1, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '5.66', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '5.71', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 1, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '6.44', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '5.73', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 1, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '6.86', 'groupId': 'OG000'}, {'value': '-5.7', 'spread': '6.14', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 1, 12 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '7.29', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '6.55', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 1, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '5.85', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '4.60', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 2, Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 2, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '7.15', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '5.57', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 2, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '5.35', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '6.23', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 2, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '3.53', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '4.06', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 2, 12 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '5.55', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '5.70', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 2, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '5.13', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '5.93', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 3, Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 3, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.3', 'spread': '6.77', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '5.09', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 3, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '5.12', 'groupId': 'OG000'}, {'value': '-5.7', 'spread': '4.37', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 3, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'spread': '6.82', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '6.18', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 3, 12 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.9', 'spread': '5.03', 'groupId': 'OG000'}, {'value': '-5.6', 'spread': '5.15', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 3, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '3.83', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '4.89', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 4, Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 4, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'spread': '5.69', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '4.60', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 4, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '4.25', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '5.24', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 4, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '4.35', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '4.34', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 4, 12 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '4.32', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '5.62', 'groupId': 'OG001'}]}]}, {'title': 'DBP - Period 4, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '4.52', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '4.38', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 1, Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 1, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '5.09', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '4.10', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 1, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '5.50', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '4.98', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 1, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '5.30', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '6.21', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 1, 12 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '5.69', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '4.63', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 1, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '5.61', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '5.72', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 2, Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 2, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.4', 'spread': '7.60', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '3.39', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 2, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '6.09', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '5.35', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 2, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '5.90', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '5.12', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 2, 12 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '6.08', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '4.64', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 2, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '5.93', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '6.10', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 3, Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 3, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.5', 'spread': '4.95', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '4.58', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 3, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '5.42', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '4.98', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 3, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'spread': '5.18', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '4.84', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 3, 12 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '4.27', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '5.32', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 3, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '4.17', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '4.13', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 4, Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 4, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '4.18', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '3.82', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 4, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '5.30', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '4.67', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 4, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '4.34', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '3.66', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 4, 12 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '4.99', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '5.67', 'groupId': 'OG001'}]}]}, {'title': 'SBP - Period 4, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '4.27', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '3.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period', 'description': 'Diastolic blood pressure (DBP) and systolic blood pressure (SBP) were collected in sitting position.', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. As pre-specified in SAP, data for safety was collected and reported across two treatment groups as participants were randomized in either of the two treatment sequences (TRTR or RTRT) at the start of the study and they remained in the same sequence until end of the study. Each participant was counted once throughout the study for this analysis. Only those participants with data available in specified categories have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Signs: Respiratory Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TRTR', 'description': 'Participants were orally administered with 400 milligram (mg) Albendazole Indian Pharmacopoeia (IP) - (T) tablet as single dose treatment under fed conditions on Day 1 in Period 1, followed by single dose treatment of 400 mg albendazole (R) tablets in Period 2, then 400 mg single dose of albendazole (T) further followed by 400 mg single dose of albendazole (R)'}, {'id': 'OG001', 'title': 'RTRT', 'description': 'Participants were orally administered with 400 milligram (mg) Albendazole (R) tablet as single dose treatment under fed conditions on Day 1 in Period 1, followed by single dose treatment of 400 mg albendazole (T) tablets in Period 2, then 400 mg single dose of albendazole (R) further followed by 400 mg single dose of albendazole (T)'}], 'classes': [{'title': 'Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '3.72', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '2.26', 'groupId': 'OG001'}]}]}, {'title': 'Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '3.56', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '3.91', 'groupId': 'OG001'}]}]}, {'title': 'Period 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '3.27', 'groupId': 'OG001'}]}]}, {'title': 'Period 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '3.41', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '3.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After Check-in (Baseline) and before Check-out for each period (each period is of 1 day)', 'description': 'Respiratory rate was collected in sitting position.', 'unitOfMeasure': 'breaths per minute (bpm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. As pre-specified in SAP, data for safety was collected and reported across two treatment groups as participants were randomized in either of the two treatment sequences (TRTR or RTRT) at the start of the study and they remained in the same sequence until end of the study. Each participant was counted once throughout the study for this analysis. Only those participants with data available in specified categories have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Signs: Radial Pulse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TRTR', 'description': 'Participants were orally administered with 400 milligram (mg) Albendazole Indian Pharmacopoeia (IP) - (T) tablet as single dose treatment under fed conditions on Day 1 in Period 1, followed by single dose treatment of 400 mg albendazole (R) tablets in Period 2, then 400 mg single dose of albendazole (T) further followed by 400 mg single dose of albendazole (R)'}, {'id': 'OG001', 'title': 'RTRT', 'description': 'Participants were orally administered with 400 milligram (mg) Albendazole (R) tablet as single dose treatment under fed conditions on Day 1 in Period 1, followed by single dose treatment of 400 mg albendazole (T) tablets in Period 2, then 400 mg single dose of albendazole (R) further followed by 400 mg single dose of albendazole (T)'}], 'classes': [{'title': 'Period 1, Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Period 1, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '6.86', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '7.79', 'groupId': 'OG001'}]}]}, {'title': 'Period 1, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '7.57', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '9.23', 'groupId': 'OG001'}]}]}, {'title': 'Period 1, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '7.87', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '7.71', 'groupId': 'OG001'}]}]}, {'title': 'Period 1, 12 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '8.85', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '7.89', 'groupId': 'OG001'}]}]}, {'title': 'Period 1, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '7.64', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '7.96', 'groupId': 'OG001'}]}]}, {'title': 'Period 2, Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Period 2, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'spread': '5.08', 'groupId': 'OG000'}, {'value': '-5.9', 'spread': '5.40', 'groupId': 'OG001'}]}]}, {'title': 'Period 2, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.5', 'spread': '5.05', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '6.23', 'groupId': 'OG001'}]}]}, {'title': 'Period 2, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '5.95', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '6.98', 'groupId': 'OG001'}]}]}, {'title': 'Period 2, 12 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '5.71', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '8.41', 'groupId': 'OG001'}]}]}, {'title': 'Period 2, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '5.58', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '6.47', 'groupId': 'OG001'}]}]}, {'title': 'Period 3, Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Period 3, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.0', 'spread': '6.41', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '6.70', 'groupId': 'OG001'}]}]}, {'title': 'Period 3, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.8', 'spread': '5.47', 'groupId': 'OG000'}, {'value': '-4.7', 'spread': '7.09', 'groupId': 'OG001'}]}]}, {'title': 'Period 3, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.9', 'spread': '6.32', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '7.72', 'groupId': 'OG001'}]}]}, {'title': 'Period 3, 12 Hrs Post Dose3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '7.82', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '7.07', 'groupId': 'OG001'}]}]}, {'title': 'Period 3, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.7', 'spread': '6.73', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '7.71', 'groupId': 'OG001'}]}]}, {'title': 'Period 4, Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Period 4, 2 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.4', 'spread': '8.94', 'groupId': 'OG000'}, {'value': '-6.5', 'spread': '8.23', 'groupId': 'OG001'}]}]}, {'title': 'Period 4, 4 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '8.16', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '8.44', 'groupId': 'OG001'}]}]}, {'title': 'Period 4, 6 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '7.09', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '6.53', 'groupId': 'OG001'}]}]}, {'title': 'Period 4, 12 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'spread': '7.27', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '7.30', 'groupId': 'OG001'}]}]}, {'title': 'Period 4, 24 Hrs Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.1', 'spread': '7.73', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '8.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period', 'description': 'Radial pulse was collected in sitting position.', 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. As pre-specified in SAP, data for safety was collected and reported across two treatment groups as participants were randomized in either of the two treatment sequences (TRTR or RTRT) at the start of the study and they remained in the same sequence until end of the study. Each participant was counted once throughout the study for this analysis. Only those participants with data available in specified categories have been analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test(T) Albendazole vs Reference(R) Albendazole First,Then (T) Albendazole vs (R) Albendazole (TRTR)', 'description': 'Participants were orally administered with Albendazole \\[Indian Pharmacopoeia (IP)\\] 400 mg (T1) tablet as single dose treatment under fed conditions on Day 1 in Period 1, followed by single dose of Albendazole 400 mg (R1) tablet in Period 2, then single dose Albendazole IP 400 mg (T2) tablet in Period 3 further followed by single dose Albendazole 400 mg (R2) tablet in Period 4'}, {'id': 'FG001', 'title': '(R) Albendazole vs (T) Albendazole First,Then (R) Albendazole vs (T) Albendazole (RTRT)', 'description': 'Participants were orally administered with Albendazole 400 mg (R1) tablet as single dose treatment under fed conditions on Day 1 in Period 1, followed by single dose of Albendazole IP 400 mg (T1) tablet in Period 2, then single dose Albendazole 400 mg (R2) tablet in Period 3 further followed by single dose Albendazole IP 400 mg (T2) tablet in Period 4'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'One participant discontinued on own accord from Period 2 but was present in periods 3 and 4. This participant has completed the study.', 'groupId': 'FG000', 'numSubjects': '34'}, {'comment': 'One participant withdrew from the study after completing Period 1.', 'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'One participant withdrew from the study after completing periods 1, 2 and 3, and another participant discontinued from Period 4 on medical ground but did not withdraw from the study.', 'groupId': 'FG000', 'numSubjects': '33'}, {'comment': 'One participant withdrew from the study after completing periods 1, 2 and 3, and another participant discontinued on own accord from Period 4 but did not withdraw from the study.', 'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Test(T) Albendazole vs Reference(R) Albendazole First,Then (T) Albendazole vs (R) Albendazole (TRTR)', 'description': 'Participants were orally administered with Albendazole \\[Indian Pharmacopoeia (IP)\\] 400 mg (T1) tablet as single dose treatment under fed conditions on Day 1 in Period 1, followed by single dose of Albendazole 400 mg (R1) tablet in Period 2, then single dose Albendazole IP 400 mg (T2) tablet in Period 3 further followed by single dose Albendazole 400 mg (R2) tablet in Period 4'}, {'id': 'BG001', 'title': '(R) Albendazole vs (T) Albendazole First,Then (R) Albendazole vs (T) Albendazole (RTRT)', 'description': 'Participants were orally administered with Albendazole 400 mg (R1) tablet as single dose treatment under fed conditions on Day 1 in Period 1, followed by single dose of Albendazole IP 400 mg (T1) tablet in Period 2, then single dose Albendazole 400 mg (R2) tablet in Period 3 further followed by single dose Albendazole IP 400 mg (T2) tablet in Period 4'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32', 'spread': '5.25', 'groupId': 'BG000'}, {'value': '34.5', 'spread': '6.40', 'groupId': 'BG001'}, {'value': '33.2', 'spread': '5.94', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-04', 'size': 860652, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-09-11T02:20', 'hasProtocol': True}, {'date': '2023-10-04', 'size': 3547182, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-09-11T02:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2023-12-30', 'resultsFirstSubmitDate': '2024-09-11', 'studyFirstSubmitQcDate': '2023-12-30', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-17', 'studyFirstPostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax) of Albendazole', 'timeFrame': 'Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours', 'description': 'Blood samples were collected for pharmacokinetic (PK) analysis of Albendazole. PK parameter was determined using standard non-compartmental methods.'}, {'measure': 'Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] for Albendazole', 'timeFrame': 'Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours', 'description': 'Blood samples were collected for PK analysis of Albendazole. PK parameter was determined using standard non-compartmental methods.'}], 'secondaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax) of Albendazole Sulfoxide', 'timeFrame': 'Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours', 'description': 'Blood samples were collected for PK analysis of Albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.'}, {'measure': 'Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] of Albendazole Sulfoxide', 'timeFrame': 'Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours', 'description': 'Blood samples were collected for PK analysis of Albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.'}, {'measure': 'Area Under the Plasma Concentration-time Curve Extrapolated to Infinity [AUC0-inf] of Albendazole and Albendazole Sulfoxide', 'timeFrame': 'Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours', 'description': 'Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.'}, {'measure': 'Time Until Cmax is Reached (Tmax) for Albendazole and Albendazole Sulfoxide', 'timeFrame': 'Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours', 'description': 'Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.'}, {'measure': 'Plasma Concentration Half-life (t1/2) of Albendazole and Albendazole Sulfoxide', 'timeFrame': 'Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours', 'description': 'Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.'}, {'measure': 'Terminal Elimination Rate Constant (Lambda-z (λz)) of Albendazole and Albendazole Sulfoxide', 'timeFrame': 'Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours', 'description': 'Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.'}, {'measure': 'Observed Percentage of Extrapolated Area Under Concentration (AUC_% Extrap_obs) for Albendazole and Albendazole Sulfoxide', 'timeFrame': 'Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours', 'description': 'Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to 22 days', 'description': 'A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.'}, {'measure': 'Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)', 'timeFrame': 'At pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours (Hrs) post-dose in each period', 'description': 'Diastolic blood pressure (DBP) and systolic blood pressure (SBP) were collected in sitting position.'}, {'measure': 'Absolute Values of Vital Signs: Respiratory Rate', 'timeFrame': 'At screening, after check-in and before check-out in each period (each period is of 1 day)', 'description': 'Respiratory rate was collected in sitting position.'}, {'measure': 'Absolute Values of Vital Signs: Radial Pulse', 'timeFrame': 'At pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period (each period is of 1 day)', 'description': 'Radial pulse was collected in sitting position.'}, {'measure': 'Change From Baseline in Vital Signs: Blood Pressure', 'timeFrame': 'Pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period', 'description': 'Diastolic blood pressure (DBP) and systolic blood pressure (SBP) were collected in sitting position.'}, {'measure': 'Change From Baseline in Vital Signs: Respiratory Rate', 'timeFrame': 'After Check-in (Baseline) and before Check-out for each period (each period is of 1 day)', 'description': 'Respiratory rate was collected in sitting position.'}, {'measure': 'Change From Baseline in Vital Signs: Radial Pulse', 'timeFrame': 'pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period', 'description': 'Radial pulse was collected in sitting position.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Albendazole', 'Bioequivalence'], 'conditions': ['Intestinal Diseases']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to compare two formulations of Albendazole of the same dose in healthy adult participants. Researchers will compare the extent and rate to which the drug is absorbed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy, non-smoker, adult participants having body mass index (BMI) between 18.5 to 30.0 (both inclusive), calculated as weight in kilogram (kg)/ height in meter square (m2)\n2. Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead electrocardiogram (ECG) and X-ray chest (postero-anterior view) recordings.\n3. Able to understand and adhere to the study procedures\n4. Voluntary written informed consent is given for study participation\n5. In case of female participants:\n\nSurgically sterilized at least 6 months prior to study participation;Or If of childbearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study, And Serum pregnancy test must be negative.\n\nExclusion Criteria:\n\n1. Known hypersensitivity or idiosyncratic reaction to albendazole or any excipients or any related drug or any substance.\n2. History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.\n3. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or non-steroidal anti inflammatory drugs (NSAIDs) induced urticaria.\n4. History or presence of seizure or psychiatric disorders.\n5. Ingestion of a medication (prescribed medication \\& over the counter (OTC) medication, herbal remedies, cimetidine, praziquantel, dexamethasone, ritonavir, phenytoin, carbamazepine, phenobarbital) at any time in 14 days prior to dosing and any vaccine (including COVID-19 vaccine) from 14 days prior to dosing. In any such case participant selection will be at the discretion of the Principal Investigator.\n6. Receipt of an intervention or participation in a drug research study within a period of 90 days prior to the first dose of study intervention \\*\\*.\n\n * If intervention is received within 90 days where there is no blood loss except safety lab testing, participant can be included considering 10 half-lives duration of intervention received.\n7. A positive hepatitis screen including hepatitis B surface antigen and/or hepatitis C virus (HCV) antibodies.\n8. A positive test result for HIV antibody (1 and/or 2).\n9. The presence of clinically significant abnormal laboratory values during screening.'}, 'identificationModule': {'nctId': 'NCT06201559', 'briefTitle': 'Bioequivalence Study Between Two Albendazole 400 mg Tablets in Healthy Adult Participants Under Fed Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Open Label, Balanced, Randomized, Two-Treatment, Four-Period, Two-Sequence, Single Oral Dose, Full Replicate Crossover, Bioequivalence Study of Albendazole Tablets IP 400 mg of Biddle Sawyer Limited (GSK Group Company) With Albendazole Tablets 400 mg of Glaxo SmithKline Consumer Healthcare, South Africa (PTY) Ltd in Healthy, Adult Participants Under Fed Condition', 'orgStudyIdInfo': {'id': '221030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence TRTR', 'description': 'Participants will be administered with test (T) intervention \\[Albendazole Indian Pharmacopoeia (IP) 400 mg\\] in Period 1, reference (R) intervention (Albendazole Tablets 400 mg) in Period 2, T intervention in Period 3 and R intervention in Period 4.', 'interventionNames': ['Drug: Albendazole IP 400 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence RTRT', 'description': 'Participants will be administered with reference (R) intervention in Period 1, test (T) intervention in Period 2, R intervention in Period 3 and T intervention in Period 4.', 'interventionNames': ['Drug: Albendazole 400 mg']}], 'interventions': [{'name': 'Albendazole IP 400 mg', 'type': 'DRUG', 'description': 'Albendazole IP 400 mg tablets will be administered under fed conditions', 'armGroupLabels': ['Sequence TRTR']}, {'name': 'Albendazole 400 mg', 'type': 'DRUG', 'description': 'Albendazole 400 mg tablets will be administered under fed conditions', 'armGroupLabels': ['Sequence RTRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '382481', 'city': 'Ahmedabad', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}]}, 'ipdSharingStatementModule': {'url': 'https://www.gsk.com/en-gb/innovation/trials/data-transparency/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.', 'ipdSharing': 'YES', 'description': "Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/", 'accessCriteria': 'Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}