Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-29 @ 9:01 PM
Study NCT ID:
NCT00961857
Status:
COMPLETED
Last Update Posted:
2019-11-13
First Post:
2009-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Concomitant Administration of Sitagliptin and Metformin as Individual Tablets (0431A-048)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2006-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-08', 'studyFirstSubmitDate': '2009-08-18', 'studyFirstSubmitQcDate': '2009-08-18', 'lastUpdatePostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The area under the plasma concentration vs. time curve (AUC) after administration of sitagliptin/metformin (50/500 and 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets', 'timeFrame': '72 hours post dose'}], 'secondaryOutcomes': [{'measure': 'Peak plasma concentration (Cmax) of sitagliptin and metformin after administration of sitagliptin/metformin (50/500 and 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets', 'timeFrame': '72 hours post dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '20923244', 'type': 'RESULT', 'citation': 'Migoya EM, Miller JL, Gutierrez M, Zheng W, Johnson-Levonas AO, Liu Q, Matthews CZ, Wagner JA, Gottesdiener KM. Bioequivalence of sitagliptin/metformin fixed-dose combination tablets and concomitant administration of sitagliptin and metformin in healthy adult subjects: a randomized, open-label, crossover study. Clin Drug Investig. 2010;30(12):855-66. doi: 10.1007/BF03256914.'}]}, 'descriptionModule': {'briefSummary': 'A two-part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin /metformin (50/500 and 50/1000 mg) Fixed-Dose Combination (FDC) tablet and co-administration of a single dose of sitagliptin (50 mg) and metformin ( 500 or 1000 mg) as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I) or Treatment C and D (Part II).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female subjects of reproductive potential test negative for pregnancy and agree to use appropriate contraception\n* Subject is in good health and is a non-smoker\n* Subject is willing to avoid strenuous physical activity during the study\n* Subject agrees to refrain from eating grapefruit or grapefruit products during the study\n\nExclusion Criteria:\n\n* Subject has a history of neoplastic disease (cancer), stroke, chronic seizures, or major neurological disorder. Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases\n* Subject consumes excessive amounts of alcohol or caffeinated beverages\n* Subject has donated blood, had surgery or participated in another clinical study within the past 4 weeks\n* Subject has a history of significant multiple and/or severe allergies to prescription or non-prescription drugs or food\n* Subject has a history of hypersensitivity to metformin, sitagliptin, or sitagliptin/Metformin\n* Subject is a regular user or past abuser of any illicit drugs\n* Subject is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies during the study.\n* Subject is a nursing mother'}, 'identificationModule': {'nctId': 'NCT00961857', 'briefTitle': 'A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Concomitant Administration of Sitagliptin and Metformin as Individual Tablets (0431A-048)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-label, Randomized Two-Part, Two-Period Crossover Study to Demonstrate the Definitive Bioequivalence After Administration of Final Market Image (FMI) Sitagliptin /Metformin 50/500 mg and 50/1000 mg Fixed Dose Combination (FDC) and Concomitant Administration of 50 mg Doses of Sitagliptin and 500 or 1000 mg Doses of Metformin as Individual Tablets', 'orgStudyIdInfo': {'id': '0431A-048'}, 'secondaryIdInfos': [{'id': 'MK0431A-048'}, {'id': '2009_635'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment A', 'description': 'Individual Tablets of 50 mg sitagliptin and 500 mg metformin', 'interventionNames': ['Drug: sitagliptin phosphate (+) metformin hydrochloride', 'Drug: Comparator: metformin 500 mg', 'Drug: Comparator: sitagliptin']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'description': 'Sitagliptin/metformin 50 mg/500 mg tablet', 'interventionNames': ['Drug: Comparator: FMI sitagliptin/metformin 50 mg/500 mg FDC tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment C', 'description': 'Individual Tablets of 50 mg sitagliptin and 1000 mg metformin', 'interventionNames': ['Drug: Comparator: sitagliptin', 'Drug: Comparator: metformin 1000 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment D', 'description': 'sitagliptin/metformin 50 mg/1000 mg tablet', 'interventionNames': ['Drug: Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet']}], 'interventions': [{'name': 'sitagliptin phosphate (+) metformin hydrochloride', 'type': 'DRUG', 'description': 'place holder - do not post', 'armGroupLabels': ['Treatment A']}, {'name': 'Comparator: metformin 500 mg', 'type': 'DRUG', 'otherNames': ['Apotex'], 'description': 'A single dose of metformin 500 mg tablets', 'armGroupLabels': ['Treatment A']}, {'name': 'Comparator: sitagliptin', 'type': 'DRUG', 'description': 'A single 50 mg tablet of sitagliptin', 'armGroupLabels': ['Treatment A', 'Treatment C']}, {'name': 'Comparator: FMI sitagliptin/metformin 50 mg/500 mg FDC tablet', 'type': 'DRUG', 'description': 'A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet', 'armGroupLabels': ['Treatment B']}, {'name': 'Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet', 'type': 'DRUG', 'description': 'A single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet', 'armGroupLabels': ['Treatment D']}, {'name': 'Comparator: metformin 1000 mg', 'type': 'DRUG', 'otherNames': ['Apotex'], 'description': 'A single dose of metformin 1000 mg tablets', 'armGroupLabels': ['Treatment C']}]}, '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'}}}}