Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT00649493
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2008-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fed Study of Rabeprazole Sodium Tablets 20 mg and Aciphex® Tablets 20 mg
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064750', 'term': 'Rabeprazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-22', 'studyFirstSubmitDate': '2008-03-30', 'studyFirstSubmitQcDate': '2008-03-31', 'lastUpdatePostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-06', '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': 'blood collections through 24 hours'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mpibiostudies.com', 'label': 'Mylan Pharmaceuticals Inc. - Clinical Trial Results'}, {'url': 'http://dailymed.nlm.nih.gov/dailymed/about.cfm', 'label': 'Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use'}, {'url': 'http://www.fda.gov/opacom/7alerts.html', 'label': 'Recalls, Market Withdrawals and Safety Alerts'}]}, 'descriptionModule': {'briefSummary': "The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium 20 mg tablets to Eisai's Aciphex® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fed conditions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 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': 'NCT00649493', 'briefTitle': 'Fed Study of Rabeprazole Sodium Tablets 20 mg and Aciphex® Tablets 20 mg', 'organization': {'class': 'INDUSTRY', 'fullName': 'Viatris Inc.'}, 'officialTitle': 'Single-Dose Food In Vivo Bioequivalence Study of Rabeprazole Sodium Tablets (20 mg; Mylan) and Aciphex® Tablets (20 mg; Eisai) in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'RABE-0326'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Rabeprazole Sodium Tablets 20 mg', 'interventionNames': ['Drug: Rabeprazole Sodium Tablets 20 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Aciphex® Tablets 20 mg', 'interventionNames': ['Drug: Aciphex® Tablets 20 mg']}], 'interventions': [{'name': 'Rabeprazole Sodium Tablets 20 mg', 'type': 'DRUG', 'description': '20mg, single dose fed', 'armGroupLabels': ['1']}, {'name': 'Aciphex® Tablets 20 mg', 'type': 'DRUG', 'description': '20mg, single dose fed', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58104', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'PRACS Institute, Ltd.', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}], 'overallOfficials': [{'name': 'James D Carlson, Pharm. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PRACS Institute Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mylan Pharmaceuticals Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Wayne Talton', 'oldOrganization': 'Mylan Inc.'}}}}