Status:
COMPLETED
Bioequivalency Study of Buprenorphine Hydrochloride 8 mg Tablet Under Fasted Conditions
Lead Sponsor:
Roxane Laboratories
Conditions:
Opioid-Related Disorders
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
The objective of this study was to prove the bioequivalence of Buprenorphine HCl 8 mg tablet under fasted conditions.
Eligibility Criteria
Inclusion
- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00992095
Start Date
August 1 2006
End Date
September 1 2006
Last Update
January 23 2018
Active Locations (1)
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1
CEDRA Clinical Research
Austin, Texas, United States, 78759