At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 20 enrolled
Drug / intervention
Buprenorphine transdermal patch +2 moredrug
Likely dose
Buprenorphine transdermal patch 10 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single Center, Randomized, Double-Blind, Crossover Study to Assess Buprenorphine Accumulation and Description of Its Metabolites During Co-Medication of BTDS and Ketoconazole, Used As a CYP3A4 Inhibitor, in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Buprenorphine transdermal patch, Ketoconazole tablet, and 1 other intervention for Healthy. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the pharmacokinetics of buprenorphine and its metabolites in the presence and absence of ketoconazole.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2002
Primary CompletionJun 2003
First PostedDec 2010
TodayJul 2026
First PostedDec 13, 2010
Enrollment StartOct 1, 2002
Primary CompletionJun 1, 2003
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 15.6 years ago
Interventions
Buprenorphine transdermal patchdrug
Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.
Ketoconazole tabletdrug
Ketoconazole 200 mg tablets taken orally twice daily.
Placebo to match ketoconazole tabletdrug
Placebo to match ketoconazole 200 mg tablets taken orally twice daily.