Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-31 @ 5:42 PM
Study NCT ID:
NCT01012934
Status:
COMPLETED
Last Update Posted:
2009-11-13
First Post:
2009-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fasting Study of Alendronate Sodium Tablets (70 mg) and Fosamax Tablets (70 mg)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019386', 'term': 'Alendronate'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2002-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-12', 'studyFirstSubmitDate': '2009-09-21', 'studyFirstSubmitQcDate': '2009-11-12', 'lastUpdatePostDateStruct': {'date': '2009-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.', 'timeFrame': 'urine collection up to 36 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mpibiostudies.com', 'label': 'Mylan Pharmaceuticals Inc. - Clinical Trial Results'}]}, 'descriptionModule': {'briefSummary': "The objective of this study is to investigate the bioequivalence of Mylan's alendronate sodium 70 mg tablets to Merck's Fosamax 70 mg tablets following a single, oral 70 mg (1 x 70 mg) dose administration under fasting conditions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy, adult subjects, 18 years and older\n* able to swallow medication\n\nExclusion Criteria:\n\n* institutionalized subjects\n* history of any significant disease\n* use of any prescription or OTC medications within 14 days of start of study\n* received any investigational products within 30 days prior to start of study'}, 'identificationModule': {'nctId': 'NCT01012934', 'briefTitle': 'Fasting Study of Alendronate Sodium Tablets (70 mg) and Fosamax Tablets (70 mg)', 'organization': {'class': 'UNKNOWN', 'fullName': 'MylanPharma'}, 'officialTitle': 'Single-Dose Fasting In Vivo Bioequivalence Study of Alendronate Sodium Tablets (70 mg; Mylan) and Fosamax Tablets (70 mg; Merck) in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'ALEN-0244'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Alendronate Sodium Tablets, 70 mg', 'interventionNames': ['Drug: Alendronate Sodium Tablets, 70 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Fosamax Tablets, 70 mg', 'interventionNames': ['Drug: Fosamax Tablets, 70 mg']}], 'interventions': [{'name': 'Alendronate Sodium Tablets, 70 mg', 'type': 'DRUG', 'description': '1 x 70 mg, single-dose fasting', 'armGroupLabels': ['1']}, {'name': 'Fosamax Tablets, 70 mg', 'type': 'DRUG', 'description': '1 x 70 mg, single-dose fasting', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58104', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'PRACS Insitute Ltd.', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mylan Pharmaceuticals Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Wayne Talton', 'oldOrganization': 'Mylan Inc.'}}}}