Bioequivalency Study of Buprenorphine Hydrochloride 8 mg Tablet Under Fasted Conditions

Roxane Laboratories

Status: Completed

Conditions: Opioid-Related Disorders

Treatments: Drug: buprenorphine hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00992095

BUPR-T8-PVFS-1

Details and patient eligibility

About

The objective of this study was to prove the bioequivalence of Buprenorphine HCl 8 mg tablet under fasted conditions.

Enrollment: 48 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion criteria

• Positive test for HIV, Hepatitis B, or Hepatitis C.
• Treatment with known enzyme altering drugs. History of allergic or adverse response to buprenorphine hydrochloride or any comparable or similar product.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)