Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-30 @ 10:20 AM
Study NCT ID:
NCT01093794
Status:
COMPLETED
Last Update Posted:
2015-07-28
First Post:
2010-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. SPONSOR review can be expedited to meet publication guidelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sit 50 mg + Met 500 mg', 'description': 'AEs reported in participants after co-administration of 50 mg sitagliptin and 500 mg metformin.', 'otherNumAtRisk': 28, 'otherNumAffected': 4, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sit/Met 50 mg/500 mg FDC', 'description': 'AEs reported in participants after administration of the sitagliptin/metformin 50 mg/500 mg fixed dose combination (FDC) tablet.', 'otherNumAtRisk': 28, 'otherNumAffected': 3, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Sit 50 mg + Met 850 mg', 'description': 'AEs reported in participants after co-administration of 50 mg sitagliptin and 850 mg metformin.', 'otherNumAtRisk': 28, 'otherNumAffected': 4, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Sit/Met 50 mg/850 mg FDC', 'description': 'AEs reported in participants after administration of sitagliptin 50 mg/metformin 850 mg FDC tablet.', 'otherNumAtRisk': 28, 'otherNumAffected': 2, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Leucocytosis', 'notes': 'Laboratory finding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Curve (AUC(0-t)) for Sitagliptin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sit 50 mg + Met 500 mg', 'description': 'Participants co-administered 50 mg sitagliptin and 500 mg metformin as individual tablets from all treatment sequences.'}, {'id': 'OG001', 'title': 'SitMet 50mg/500mg FDC', 'description': 'Participants administered the sitagliptin/metformin 50 mg/500 mg FDC tablet from all treatment sequences.'}, {'id': 'OG002', 'title': 'Sit 50 mg + Met 850 mg', 'description': 'Participants co-administered 50 mg sitagliptin and 850mg metformin as individual tablets from all treatment sequences.'}, {'id': 'OG003', 'title': 'SitMet 50mg/850mg FDC', 'description': 'Participants administered sitagliptin/metformin 50 mg/850 mg FDC tablet from all treatment sequences.'}], 'classes': [{'title': 'sitagliptin 50 mg', 'categories': [{'measurements': [{'value': '1570', 'spread': '217.40', 'groupId': 'OG000'}, {'value': '1590', 'spread': '186.58', 'groupId': 'OG001'}, {'value': '1520', 'spread': '228.83', 'groupId': 'OG002'}, {'value': '1600', 'spread': '195.05', 'groupId': 'OG003'}]}]}, {'title': 'metformin 500 mg', 'categories': [{'measurements': [{'value': '8350', 'spread': '1881.70', 'groupId': 'OG000'}, {'value': '8750', 'spread': '1920.45', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Metformin 500 mg was not administered during this treatment.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Metformin 500 mg was not administered during this treatment.', 'groupId': 'OG003'}]}]}, {'title': 'metformin 850 mg', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Metformin 850 mg was not administered during this treatment.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Metformin 850 mg was not administered during this treatment.', 'groupId': 'OG001'}, {'value': '11800', 'spread': '2849.36', 'groupId': 'OG002'}, {'value': '13100', 'spread': '2987.28', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline through 72 hours postdose', 'description': 'AUC (0-t) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol (PP) set: Participants who completed the study according to the protocol. One participant who discontinued after Treatment Period 1 was not included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Cmax for Sitagliptin and Metformin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sit 50 mg + Met 500 mg', 'description': 'Participants co-administered 50 mg sitagliptin and 500 mg metformin as individual tablets from all treatment sequences.'}, {'id': 'OG001', 'title': 'SitMet 50mg/500mg FDC', 'description': 'Participants administered the sitagliptin/metformin 50 mg/500 mg FDC tablet from all treatment sequences.'}, {'id': 'OG002', 'title': 'Sit 50 mg + Met 850 mg', 'description': 'Participants co-administered 50 mg sitagliptin and 850mg metformin as individual tablets from all treatment sequences.'}, {'id': 'OG003', 'title': 'SitMet 50mg/850mg FDC', 'description': 'Participants administered sitagliptin/metformin 50 mg/850 mg FDC tablet from all treatment sequences.'}], 'classes': [{'title': 'sitagliptin 50 mg', 'categories': [{'measurements': [{'value': '189', 'spread': '37.76', 'groupId': 'OG000'}, {'value': '182', 'spread': '38.71', 'groupId': 'OG001'}, {'value': '187', 'spread': '40.31', 'groupId': 'OG002'}, {'value': '194', 'spread': '32.67', 'groupId': 'OG003'}]}]}, {'title': 'Metformin 500 mg', 'categories': [{'measurements': [{'value': '1210', 'spread': '323.83', 'groupId': 'OG000'}, {'value': '1310', 'spread': '383.57', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Metformin 500 mg was not administered during this treatment.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Metformin 500 mg was not administered during this treatment.', 'groupId': 'OG003'}]}]}, {'title': 'Metformin 850 mg', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Metformin 850 mg was not administered during this treatment.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Metformin 850 mg was not administered during this treatment.', 'groupId': 'OG001'}, {'value': '1790', 'spread': '488.51', 'groupId': 'OG002'}, {'value': '1970', 'spread': '482.69', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline through 72 hours postdose', 'description': 'Cmax is the peak serum concentration of a therapeutic drug after administration; and is used to determine the rate and extent of drug absorption. Cmax is reported for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol (PP) set: Participants who completed the study according to the protocol. One participant who discontinued after Treatment Period 1 was not included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850', 'description': 'Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:\n\n* Co-administration of 50 mg sitagliptin and 500 mg metformin\n* sitagliptin/metformin 50 mg/500 mg FDC tablet\n* sitagliptin/metformin 50 mg/850 mg FDC tablet\n* Co-administration of 50 mg sitagliptin and 850 mg metformin'}, {'id': 'FG001', 'title': '2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC', 'description': 'Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:\n\n* sitagliptin/metformin 50 mg/500 mg FDC tablet\n* Co-administration of 50 mg sitagliptin and 850 mg metformin\n* Co-administration of 50 mg sitagliptin and 500mg metformin\n* sitagliptin/metformin 50 mg/850 mg FDC tablet'}, {'id': 'FG002', 'title': '3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500', 'description': 'Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:\n\n* Co-administration of 50 mg sitagliptin and 850 mg metformin\n* sitagliptin/metformin 50 mg/850 mg FDC tablet\n* sitagliptin/metformin 50 mg/500 mg FDC tablet\n* Co-administration of 50 mg sitagliptin and 500mg metformin'}, {'id': 'FG003', 'title': '4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC', 'description': 'Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:\n\n* sitagliptin/metformin 50 mg/850 mg FDC tablet\n* Co-administration of 50 mg sitagliptin and 500 mg metformin\n* Co-administration of 50 mg sitagliptin and 850 mg metformin\n* sitagliptin/metformin 50 mg/500 mg FDC tablet'}], 'periods': [{'title': 'Treatment Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'comment': 'After period 1, one participant was discontinued by the investigator due to a protocol deviation.', 'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '28 participants were randomized in four treatment sequences. Participants had a 7 day minimum washout period between treatments.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'spread': '5.61', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '22', 'spread': '1.22', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-17', 'studyFirstSubmitDate': '2010-03-19', 'resultsFirstSubmitDate': '2011-06-03', 'studyFirstSubmitQcDate': '2010-03-24', 'lastUpdatePostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-06-03', 'studyFirstPostDateStruct': {'date': '2010-03-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve (AUC(0-t)) for Sitagliptin', 'timeFrame': 'baseline through 72 hours postdose', 'description': 'AUC (0-t) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.'}, {'measure': 'Cmax for Sitagliptin and Metformin', 'timeFrame': 'baseline through 72 hours postdose', 'description': 'Cmax is the peak serum concentration of a therapeutic drug after administration; and is used to determine the rate and extent of drug absorption. Cmax is reported for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'This study will test the hypothesis that the Final Market Image (FMI) sitagliptin/metformin 50 mg/500 mg and 50 mg/850 mg (Fixed Dose Combination) FDC tablet and co-administration of corresponding doses of sitagliptin and China-sourced metformin as individual tablets will be bioequivalent based on assessment of the AUC(0-t) and Cmax, for both sitagliptin and metformin.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is of Chinese descent\n* Subject is in good health\n* Subject is a non-smoker\n\nExclusion Criteria:\n\n* Subject has a history of stroke or chronic seizures\n* Subject has a history of cancer\n* Subject has had major surgery, donated blood or participated in another investigational study within the past 4 weeks'}, 'identificationModule': {'nctId': 'NCT01093794', 'briefTitle': 'Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Bioequivalence Study With Two Tablet Strengths of the Final Market Image (FMI) Sitagliptin/Metformin Fixed Dose Combination (FDC) Tablet', 'orgStudyIdInfo': {'id': '0431A-122'}, 'secondaryIdInfos': [{'id': '2010_518'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850', 'description': 'Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:\n\n* Co-administration of 50 mg sitagliptin and 500 mg metformin\n* sitagliptin/metformin 50 mg/500 mg FDC tablet\n* sitagliptin/metformin 50 mg/850 mg FDC tablet\n* Co-administration of 50 mg sitagliptin and 850 mg metformin', 'interventionNames': ['Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin', 'Drug: sitagliptin/metformin 50 mg/500 mg tablet', 'Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin', 'Drug: sitagliptin/metformin 50 mg/850 mg tablet']}, {'type': 'EXPERIMENTAL', 'label': '2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC', 'description': 'Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:\n\n* sitagliptin/metformin 50 mg/500 mg FDC tablet\n* Co-administration of 50 mg sitagliptin and 850 mg metformin\n* Co-administration of 50 mg sitagliptin and 500mg metformin\n* sitagliptin/metformin 50 mg/850 mg FDC tablet', 'interventionNames': ['Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin', 'Drug: sitagliptin/metformin 50 mg/500 mg tablet', 'Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin', 'Drug: sitagliptin/metformin 50 mg/850 mg tablet']}, {'type': 'EXPERIMENTAL', 'label': '3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500', 'description': 'Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:\n\n* Co-administration of 50 mg sitagliptin and 850 mg metformin\n* sitagliptin/metformin 50 mg/850 mg FDC tablet\n* sitagliptin/metformin 50 mg/500 mg FDC tablet\n* Co-administration of 50 mg sitagliptin and 500mg metformin', 'interventionNames': ['Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin', 'Drug: sitagliptin/metformin 50 mg/500 mg tablet', 'Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin', 'Drug: sitagliptin/metformin 50 mg/850 mg tablet']}, {'type': 'EXPERIMENTAL', 'label': '4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC', 'description': 'Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:\n\n* sitagliptin/metformin 50 mg/850 mg FDC tablet\n* Co-administration of 50 mg sitagliptin and 500 mg metformin\n* Co-administration of 50 mg sitagliptin and 850 mg metformin\n* sitagliptin/metformin 50 mg/500 mg FDC tablet', 'interventionNames': ['Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin', 'Drug: sitagliptin/metformin 50 mg/500 mg tablet', 'Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin', 'Drug: sitagliptin/metformin 50 mg/850 mg tablet']}], 'interventions': [{'name': 'Co-administration of 50 mg sitagliptin and 500 mg metformin', 'type': 'DRUG', 'description': 'Co-administration of 50 mg sitagliptin and 500 mg China-sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met500) after fasting for at least 10 hours.', 'armGroupLabels': ['1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850', '2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC', '3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500', '4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC']}, {'name': 'sitagliptin/metformin 50 mg/500 mg tablet', 'type': 'DRUG', 'description': 'Single dose administration of the final marketing image (FMI) sitagliptin/metformin 50 mg/500 mg fixed-dose combination (FDC) tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.', 'armGroupLabels': ['1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850', '2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC', '3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500', '4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC']}, {'name': 'Co-administration of 50 mg sitagliptin and 850 mg metformin', 'type': 'DRUG', 'description': 'Co-administration of 50 mg sitagliptin and 850 mg China sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met850) after fasting for at least 10 hours.', 'armGroupLabels': ['1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850', '2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC', '3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500', '4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC']}, {'name': 'sitagliptin/metformin 50 mg/850 mg tablet', 'type': 'DRUG', 'description': 'Single dose administration of the FMI sitagliptin/metformin 50 mg/850 mg FDC tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.', 'armGroupLabels': ['1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850', '2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC', '3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500', '4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}