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

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

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.