Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT01305551
Status:
WITHDRAWN
Last Update Posted:
2014-06-05
First Post:
2011-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BE Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin HCl XR Tablet Relative to a 5 mg Saxagliptin (Onglyza™) Tablet and a 500 mg Metformin HCl XR (Glifage® XR Marketed in Brazil by Merck S.A.) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States
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': 'C502994', 'term': 'saxagliptin'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'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'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-04', 'studyFirstSubmitDate': '2011-02-25', 'studyFirstSubmitQcDate': '2011-02-25', 'lastUpdatePostDateStruct': {'date': '2014-06-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of BE on single-dose pharmacokinetic parameters maximum observed concentration (Cmax) derived from Saxagliptin, 5-Hydroxy Saxagliptin and Metformin plasma concentration versus time data.', 'timeFrame': '48 hours after dosing'}, {'measure': 'Evidence of BE on single-dose pharmacokinetic parameters time of maximum observed concentration (Tmax) derived from Saxagliptin, 5-Hydroxy Saxagliptin and Metformin plasma concentration versus time data.', 'timeFrame': '48 hours after dosing'}, {'measure': 'Evidence of BE on single-dose pharmacokinetic parameters (AUC(0-T) derived from Saxagliptin, 5-Hydroxy Saxagliptin and Metformin plasma concentration versus time data.', 'timeFrame': '48 hours after dosing', 'description': 'Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))'}, {'measure': 'Evidence of BE on single-dose pharmacokinetic parameters area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) derived from Saxagliptin, 5-Hydroxy Saxagliptin and Metformin plasma concentration versus time data.', 'timeFrame': '48 hours after dosing'}, {'measure': 'Evidence of BE on single-dose pharmacokinetic parameters half-life (T-HALF) derived from Saxagliptin, 5-Hydroxy Saxagliptin and Metformin plasma concentration versus time data.', 'timeFrame': '48 hours after dosing'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '3 days after dosing'}, {'measure': 'Active metabolite of Saxagliptin, 5-Hydroxy Saxagliptin, from 5 mg Saxagliptin/500 mg Metformin XR FDC tablet & from 5 mg Onglyza administered together with 500 mg Glifage® XR in single-dose fed & fasted state pharmacokinetics in healthy subjects', 'timeFrame': '3 days after dosing', 'description': 'Amount of the active metabolite of Saxagliptin, 5-Hydroxy Saxagliptin (BMS-510849), from the 5 mg Saxagliptin/500 mg Metformin XR FDC tablet and from 5 mg Onglyza™ administered together with 500 mg Glifage® XR (marketed in Brazil by Merck S.A.) in single-dose fed and fasted state pharmacokinetics in healthy subjects'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and Metformin from a 5 mg Saxagliptin/500 mg Metformin extended release (XR) fixed dose combination (FDC) tablet relative to 5 mg Onglyza™ and 500 mg Glifage® XR (marketed in Brazil by Merck S.A.) tablets administered together in both the fasted and fed states.', 'detailedDescription': 'Primary purpose: To demonstrate the bioequivalence of Saxagliptin and Metformin from a 5 mg Saxagliptin/500 mg Metformin XR FDC tablet relative to 5 mg Onglyza™ and 500 mg Glifage® XR (marketed in Brazil by Merck S.A.) tablets administered together in both the fasted and fed states.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women\n* Women of childbearing potential (WOCBP) who are using acceptable method of contraception\n* Women who are not nursing\n\nExclusion Criteria:\n\n* History of Gastrointestinal (GI) disease\n* Any GI surgery that could impact study drug absorption\n* History of allergy to drug class or related compounds\n* History of allergy to metformin or other similar acting agents.\n* History of any significant drug allergy.\n* Estimated creatinine clearance (ClCr) \\< 80 mL/min using Cockcroft-Gault formula'}, 'identificationModule': {'nctId': 'NCT01305551', 'briefTitle': 'BE Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin HCl XR Tablet Relative to a 5 mg Saxagliptin (Onglyza™) Tablet and a 500 mg Metformin HCl XR (Glifage® XR Marketed in Brazil by Merck S.A.) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin Hydrochloride (HCl) XR Tablet Relative to a 5 mg Saxagliptin (Onglyza™) Tablet and a 500 mg Metformin HCl XR (Glifage® XR Marketed in Brazil by Merck S.A.) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States', 'orgStudyIdInfo': {'id': 'CV181-146'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A-Saxagliptin+Metformin XR', 'description': '5mg Saxagliptin + 500 mg Metformin XR Tablets, once on Day 1 only, administered together in the fasted state.', 'interventionNames': ['Drug: Saxagliptin', 'Drug: Metformin XR']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B-Saxagliptin/Metformin XR FDC', 'description': '5mg Saxagliptin / 500 mg Metformin XR FDC tablet, once on Day 1 only, administered in the fasted state.', 'interventionNames': ['Drug: Saxagliptin/Metformin XR FDC']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C-Saxagliptin+Metformin XR', 'description': '5mg Saxagliptin + 500 mg Metformin XR Tablets, once on Day 1 only, administered together in the fed state.', 'interventionNames': ['Drug: Saxagliptin', 'Drug: Metformin XR']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment D-Saxagliptin/Metformin XR FDC', 'description': '5mg Saxagliptin / 500 mg Metformin XR FDC tablet, once on Day 1 only, administered in the fed state.', 'interventionNames': ['Drug: Saxagliptin/Metformin XR FDC']}], 'interventions': [{'name': 'Saxagliptin', 'type': 'DRUG', 'otherNames': ['Onglyza'], 'description': 'Tablet, Oral, 5 mg, once on Day 1 only', 'armGroupLabels': ['Treatment A-Saxagliptin+Metformin XR', 'Treatment C-Saxagliptin+Metformin XR']}, {'name': 'Metformin XR', 'type': 'DRUG', 'otherNames': ['Glifage XR'], 'description': 'Tablet, Oral, 500 mg, once on Day 1 only', 'armGroupLabels': ['Treatment A-Saxagliptin+Metformin XR', 'Treatment C-Saxagliptin+Metformin XR']}, {'name': 'Saxagliptin/Metformin XR FDC', 'type': 'DRUG', 'otherNames': ['Onglyza/Glucophage'], 'description': 'Tablet, Oral, 5/500 mg, once on Day 1 only', 'armGroupLabels': ['Treatment B-Saxagliptin/Metformin XR FDC', 'Treatment D-Saxagliptin/Metformin XR FDC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13073', 'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Local Institution', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'Bristol-Myers Squibb'}}}}