NCT01157169

Buprenorphine 8 mg Sublingual Tablets Under Fasting Conditions

A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Buprenorphine 8 mg Sublingual Tablets Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Buprenorphine	8 mg Sublingual Tablets
DRUG	Buprenorphine	8 mg Sublingual Tablets

Timeline

• Start date: 2007-08-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2010-07-05
• Last updated: 2020-01-18
• Results posted: 2010-09-13

Locations

1 site across 1 country: United States