Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-01-03 @ 6:47 PM
Study NCT ID:
NCT00865618
Status:
COMPLETED
Last Update Posted:
2017-03-29
First Post:
2009-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fed Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077545', 'term': 'Eplerenone'}], 'ancestors': [{'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-27', 'studyFirstSubmitDate': '2009-03-18', 'studyFirstSubmitQcDate': '2009-03-18', 'lastUpdatePostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalence according to US FDA guidelines', 'timeFrame': '10 days'}]}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg Tablets Under Fed Conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', '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': 'NCT00865618', 'briefTitle': 'Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fed Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sandoz'}, 'officialTitle': 'Comparative Bioavailability Study of Eplerenone 50 mg Tablets (Sandoz Inc., USA) and Inspra 50 mg Tablets (GD Searle LLC, USA) in Healthy Male and/or Female Volunteers Under Fed Conditions.', 'orgStudyIdInfo': {'id': 'P1DX06003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Eplerenone 50mg Tablets', 'interventionNames': ['Drug: Eplerenone 50 mg Tablets Sandoz Inc., USA']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'INSPRA 50mg Tablets', 'interventionNames': ['Drug: Inspra 50 mg Tablets GD Searle LLC, USA']}], 'interventions': [{'name': 'Eplerenone 50 mg Tablets Sandoz Inc., USA', 'type': 'DRUG', 'armGroupLabels': ['1']}, {'name': 'Inspra 50 mg Tablets GD Searle LLC, USA', 'type': 'DRUG', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Deepen Patel, M.D., CCFP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Allied Research International Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sandoz', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Eric Mittleberg, Ph.D, VP of Product Development', 'oldOrganization': 'Sandoz Inc.'}}}}