Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2026-03-29 @ 11:52 PM
Study NCT ID:
NCT00992095
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2009-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalency Study of Buprenorphine Hydrochloride 8 mg Tablet Under Fasted Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002047', 'term': 'Buprenorphine'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-19', 'studyFirstSubmitDate': '2009-10-08', 'studyFirstSubmitQcDate': '2009-10-08', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bioequivalence determined by statistical comparison Cmax', 'timeFrame': '21 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Opioid-Related Disorders']}, 'descriptionModule': {'briefSummary': 'The objective of this study was to prove the bioequivalence of Buprenorphine HCl 8 mg tablet under fasted 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.\n* Treatment with known enzyme altering drugs. History of allergic or adverse response to buprenorphine hydrochloride or any comparable or similar product.'}, 'identificationModule': {'nctId': 'NCT00992095', 'briefTitle': 'Bioequivalency Study of Buprenorphine Hydrochloride 8 mg Tablet Under Fasted Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'West-Ward Pharmaceutical'}, 'officialTitle': 'A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of Buprenorphine HCl (Sublingual) 8 mg Tablets With a Naltrexone Block Under Fasting Conditions', 'orgStudyIdInfo': {'id': 'BUPR-T8-PVFS-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'buprenorphine hydrochloride', 'type': 'DRUG', 'otherNames': ['SUBUTEX'], 'description': 'single dose 8 mg sublingual tablet'}]}, 'contactsLocationsModule': {'locations': [{'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'CEDRA Clinical Research', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Fredrick A. Bieberdorf, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CEDRA Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roxane Laboratories', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Elizabeth Ernst, Director - Drug Regulatory Affairs and Medical Affairs', 'oldOrganization': 'Roxane Laboratories, Inc.'}}}}