Conditions: Healthy
Keywords: Bioequivalence Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 40
Healthy volunteers: yes

Brief 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.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Arms:
arm 1: Buprenorphine 8 mg Sublingual Tablets arm 2: Subutex® 8 mg Sublingual Tablets

Interventions: intervention 1: Buprenorphine intervention 2: Buprenorphine
Intervention descriptions: intervention 1: 8 mg Sublingual Tablets intervention 2: 8 mg Sublingual Tablets

Protocol document: