Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-02-27 @ 10:38 AM
Study NCT ID:
NCT00865033
Status:
COMPLETED
Last Update Posted:
2017-03-29
First Post:
2009-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Relative Bioavailability Study of Metformin HCL Tablets, 1000 mg Under Fasting Conditions
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': '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'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-27', 'studyFirstSubmitDate': '2009-03-15', 'studyFirstSubmitQcDate': '2009-03-18', 'lastUpdatePostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalence according to US FDA guidelines', 'timeFrame': '9 days'}]}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the relative bioequivalence of Metformin HCL Tablets, 1000 mg under fasting conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.\n\nExclusion Criteria:\n\n* Positive test results for HIV or hepatitis B or C.\n* Treatment for drug or alcohol dependence.'}, 'identificationModule': {'nctId': 'NCT00865033', 'briefTitle': 'A Relative Bioavailability Study of Metformin HCL Tablets, 1000 mg Under Fasting Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sandoz'}, 'officialTitle': 'A Relative Bioavailability Study of Metformin HCL 1000 mg Tablets Under Fasting Conditions', 'orgStudyIdInfo': {'id': 'B053709'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Metformin HCL Tablets, 1000 mg', 'interventionNames': ['Drug: Metformin HCL Tablets, 1000 mg Sandoz']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Glucophage 1000 mg Tablets', 'interventionNames': ['Drug: Glucophage 1000 mg']}], 'interventions': [{'name': 'Metformin HCL Tablets, 1000 mg Sandoz', 'type': 'DRUG', 'armGroupLabels': ['1']}, {'name': 'Glucophage 1000 mg', 'type': 'DRUG', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Soran Hong, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Novum Pharmaceutical Research Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sandoz', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Eric Mittleberg, Ph.D, VP of Product Development', 'oldOrganization': 'Sandoz Inc.'}}}}