Trials / Completed
CompletedNCT00992095
Bioequivalency Study of Buprenorphine Hydrochloride 8 mg Tablet Under Fasted Conditions
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Roxane Laboratories · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study was to prove the bioequivalence of Buprenorphine HCl 8 mg tablet under fasted conditions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | buprenorphine hydrochloride | single dose 8 mg sublingual tablet |
Timeline
- Start date
- 2006-08-01
- Primary completion
- 2006-09-01
- Completion
- 2006-09-01
- First posted
- 2009-10-09
- Last updated
- 2018-01-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00992095. Inclusion in this directory is not an endorsement.