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Bioequivalency Study of Buprenorphine Hydrochloride 8 mg Tablet Under Fasted Conditions

This study has been completed.
Information provided by:
Roxane Laboratories Identifier:
First received: October 8, 2009
Last updated: October 9, 2009
Last verified: October 2009
The objective of this study was to prove the bioequivalence of Buprenorphine HCl 8 mg tablet under fasted conditions.

Condition Intervention
Opioid-Related Disorders
Drug: buprenorphine hydrochloride

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • bioequivalence determined by statistical comparison Cmax [ Time Frame: 21 days ]

Enrollment: 48
Study Start Date: August 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: buprenorphine hydrochloride
    single dose 8 mg sublingual tablet
    Other Name: SUBUTEX

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00992095

United States, Texas
CEDRA Clinical Research
Austin, Texas, United States, 78759
Sponsors and Collaborators
Roxane Laboratories
Principal Investigator: Fredrick A. Bieberdorf, M.D. CEDRA Clinical Research
  More Information

Responsible Party: Elizabeth Ernst, Director - Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc. Identifier: NCT00992095     History of Changes
Other Study ID Numbers: BUPR-T8-PVFS-1
Study First Received: October 8, 2009
Last Updated: October 9, 2009

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists processed this record on March 29, 2017