Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
Study NCT ID:
NCT00893958
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2009-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalency Study of Mycophenolate Mofetil 500 mg Tablets Under Fed Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009173', 'term': 'Mycophenolic Acid'}], 'ancestors': [{'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-19', 'studyFirstSubmitDate': '2009-05-04', 'studyFirstSubmitQcDate': '2009-05-05', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bioequivalence determined by statistical comparison Cmax', 'timeFrame': 'baseline, 2-period, 14 day washout'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prophylaxis of Organ Rejection']}, 'descriptionModule': {'briefSummary': 'The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 500 mg tablets under fed conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening\n\nExclusion Criteria:\n\n* Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to mycophenolate mofetil or any comparable or similar product.'}, 'identificationModule': {'nctId': 'NCT00893958', 'briefTitle': 'Bioequivalency Study of Mycophenolate Mofetil 500 mg Tablets Under Fed Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'West-Ward Pharmaceutical'}, 'officialTitle': 'A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Mycophenolate Mofetil 500 mg Tablets Under Fed Conditions', 'orgStudyIdInfo': {'id': 'MYCO-T500-PVFD-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Mycophenolate Mofetil', 'type': 'DRUG', 'otherNames': ['CellCept'], 'description': 'Prophylaxis of Organ Rejection'}]}, 'contactsLocationsModule': {'locations': [{'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'CEDRA Clinical Research', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'William Allan Alexander, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CEDRA Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roxane Laboratories', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Elizabeth Ernst, Director', 'oldOrganization': 'Roxane Laboratories, Inc.'}}}}