Back to resultsBioequivalency Study of Buprenorphine Hydrochloride 8 mg Tablet Under Fasted Conditions
Primary Purpose
Opioid-Related Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
buprenorphine hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Related Disorders
Eligibility Criteria
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.
Sites / Locations
- CEDRA Clinical Research
Outcomes
Primary Outcome Measures
bioequivalence determined by statistical comparison Cmax
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00992095
Brief Title
Bioequivalency Study of Buprenorphine Hydrochloride 8 mg Tablet Under Fasted Conditions
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Roxane Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study was to prove the bioequivalence of Buprenorphine HCl 8 mg tablet under fasted conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
buprenorphine hydrochloride
Other Intervention Name(s)
SUBUTEX
Intervention Description
single dose 8 mg sublingual tablet
Primary Outcome Measure Information:
Title
bioequivalence determined by statistical comparison Cmax
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fredrick A. Bieberdorf, M.D.
Organizational Affiliation
CEDRA Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
CEDRA Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bioequivalency Study of Buprenorphine Hydrochloride 8 mg Tablet Under Fasted Conditions
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