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NCT00992095 Clinical Trial

Bioequivalency Study of Buprenorphine Hydrochloride 8 mg Tablet Under Fasted Conditions

Opioid-Related Disorders Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00992095
Other study ID # BUPR-T8-PVFS-1
Secondary ID
Status Completed
Phase N/A
First received October 8, 2009
Last updated January 19, 2018
Start date August 2006
Est. completion date September 2006

Study information
Verified date January 2018
Source West-Ward Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date September 2006
Est. primary completion date September 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• buprenorphine hydrochloride
single dose 8 mg sublingual tablet

Locations
Country Name City State
United States CEDRA Clinical Research Austin Texas

Sponsors (1)
Lead Sponsor Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary bioequivalence determined by statistical comparison Cmax 21 days
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