At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 40 enrolled
Drug / intervention
Buprenorphine +1 moredrug
Likely dose
Buprenorphine 8 mgfrom 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-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Buprenorphine 8 mg Sublingual Tablets Under Fasting Conditions.
In Brief
A Phase 1 clinical trial evaluating Buprenorphine for Healthy. Completed, enrolled 40 participants across 1 site.
Detailed Summary
The object of this study is to compare the rate and extent of absorption of an investigational formulation of buprenorphine 8 mg sublingual tablets manufactured by Barr Laboratories, Inc. to an equivalent oral dose of the commercially available reference product, Subutex® manufactured by Reckitt Benckiser, following and overnight fast of at least 10 hours.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
Primary CompletionSep 2007
First PostedJul 2010
TodayJul 2026
First PostedJul 5, 2010
Enrollment StartAug 1, 2007
Primary CompletionSep 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.0 years ago
Interventions
Buprenorphinedrug
8 mg Sublingual Tablets
Buprenorphinedrug
8 mg Sublingual Tablets