Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-27 @ 10:35 AM
Study NCT ID:
NCT00803192
Status:
COMPLETED
Last Update Posted:
2012-03-16
First Post:
2008-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fed Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015738', 'term': 'Famotidine'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'lastUpdateSubmitDate': '2012-03-15', 'studyFirstSubmitDate': '2008-12-03', 'studyFirstSubmitQcDate': '2008-12-04', 'lastUpdatePostDateStruct': {'date': '2012-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity.'}]}, 'conditionsModule': {'keywords': ['bioavailability', 'famotidine'], 'conditions': ['Bioavailability']}, 'descriptionModule': {'briefSummary': 'Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40 mg tablet under fed conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy men or women 18 years of age or older\n* body mass index below 30.0 kg/m2\n* willing to participate and sin a copy of the informed consent form\n\nExclusion Criteria:\n\n* recent history of drug or alcohol addiction or abuse\n* pregnant or lactating women\n* history of allergic response to heparin, famotidine, other H2-receptor antagonists, or other related drugs\n* evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant\n* smoking more than 25 cigarettes per day'}, 'identificationModule': {'nctId': 'NCT00803192', 'briefTitle': 'Bioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fed Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Perrigo Company'}, 'officialTitle': 'Randomized, 2-Way Crossover, Bioequivalence Study of Famotidine 40 mg Tablets Administered as 1 x 40 mg Tablet in Healthy Subjects Under Fed Conditions', 'orgStudyIdInfo': {'id': '40104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Test Drug', 'interventionNames': ['Drug: Famotidine Tablets, 40 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference Drug', 'interventionNames': ['Drug: Famotidine Tablets, 40 mg']}], 'interventions': [{'name': 'Famotidine Tablets, 40 mg', 'type': 'DRUG', 'armGroupLabels': ['Reference Drug', 'Test Drug']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Perrigo Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}