Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-01-04 @ 12:09 PM
Study NCT ID:
NCT00668967
Status:
COMPLETED
Last Update Posted:
2009-07-08
First Post:
2008-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study Of Verapamil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014700', 'term': 'Verapamil'}], 'ancestors': [{'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-07', 'studyFirstSubmitDate': '2008-04-25', 'studyFirstSubmitQcDate': '2008-04-25', 'lastUpdatePostDateStruct': {'date': '2009-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary study endpoints will be AUClast, AUCinf and Cmax of R- and S-verapamil.', 'timeFrame': '5 months'}], 'secondaryOutcomes': [{'measure': 'Secondary endpoints will include Tmax and t1/2 of R- and S-verapamil and S- and R- norverapamil, as data permit. AUClast, AUCinf and Cmax of R- and S-norverapamil as data permit.', 'timeFrame': '5 months'}, {'measure': 'Safety and tolerability as assessed by reported adverse events, safety lab test and vital signs', 'timeFrame': '5 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiovascular Diseases', 'Hypertension'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6661003&StudyName=Bioequivalence%20Study%20Of%20Verapamil', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate bioequivalence of single doses of two verapamil formulations'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and/or female subjects\n* Mass Index (BMI) of approximately 18 to 30 kg/m2\n\nExclusion Criteria:\n\n* Any condition possibly affecting drug absorption\n* A positive urine drug screen'}, 'identificationModule': {'nctId': 'NCT00668967', 'briefTitle': 'Bioequivalence Study Of Verapamil', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Bioequivalence Study Of Verapamil (Covera HS) 240 Mg Extended Release Tablets Produced By Alza Corporation, Vacaville And Pfizer Inc, Puerto Rico: A Two Sequence, Four-Way Crossover Design, Single Dose, Open-Label, Randomized Study In Healthy Volunteers', 'orgStudyIdInfo': {'id': 'A6661003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Reference', 'description': 'marketed extended release verapamil tablet', 'interventionNames': ['Drug: verapamil']}, {'type': 'OTHER', 'label': 'Test', 'description': 'reformulated extended release verapamil tablet', 'interventionNames': ['Drug: verapamil']}], 'interventions': [{'name': 'verapamil', 'type': 'DRUG', 'otherNames': ['Covera HS'], 'description': '240 mg extended release tablets once daily at bedtime for 28 days', 'armGroupLabels': ['Reference']}, {'name': 'verapamil', 'type': 'DRUG', 'otherNames': ['Covera HS'], 'description': '240 mg extended release tablets once daily at bedtime for 28 days', 'armGroupLabels': ['Test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}