Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-27 @ 11:28 PM
Study NCT ID:
NCT00702260
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2008-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalency Study of Ramipril 10 mg Capsules 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': 'D017257', 'term': 'Ramipril'}], 'ancestors': [{'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-19', 'studyFirstSubmitDate': '2008-06-19', 'studyFirstSubmitQcDate': '2008-06-19', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalence', 'timeFrame': 'Baseline, two-period, 7 day washout'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The objective of this study was to prove the bioequivalence of Ramipril 10 mg capsules 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 Ramipril or any comparable or similar product.'}, 'identificationModule': {'nctId': 'NCT00702260', 'briefTitle': 'Bioequivalency Study of Ramipril 10 mg Capsules Under Fed Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'West-Ward Pharmaceutical'}, 'officialTitle': 'A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ramipril 10 mg Capsules Under Fed Conditions', 'orgStudyIdInfo': {'id': 'RAMI-C10-PVFD-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ramipril', 'type': 'DRUG', 'description': '10 mg capsule'}]}, 'contactsLocationsModule': {'locations': [{'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'CEDRA Clinical Research, LLC', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Daniel V Freeland, D.O.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CEDRA Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roxane Laboratories', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Elizabeth Ernst, Director, DRA-MA', 'oldOrganization': 'Roxane Laboratories, Inc.'}}}}