Bioequivalency Study of Buprenorphine Hydrochloride 8 mg Tablet Under Fasted Conditions

Completed · Not applicable

Conditions studied: Opioid-Related Disorders

In brief

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

Key facts

Study ID

NCT00992095

Run by

Roxane Laboratories

People needed

48

Starts

2006-08-01

Expected to finish

2006-09-01

Last updated by the study team

2018-01-23

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• CEDRA Clinical Research — Austin, Texas, United States

Full record on ClinicalTrials.gov

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