Status:
COMPLETED
Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fasted Conditions
Lead Sponsor:
Sandoz
Conditions:
Pain
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to demonstrate the relative bioequivalence of oxymorphone hydrochloride extended-release tablets (Sandoz) with Opana extended release oxymorphone hydrochloride tablets.
Detailed Description
Bioequivalence based on FDA Criteria.
Eligibility Criteria
Inclusion
- No clinically significant abnormal findings on physical exam, medical history or clinical laboratory results on screening.
Exclusion
- Positive test results for HIV or hepatitis B or C
- Treatment for drug or alcohol dependence
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00857428
Start Date
November 1 2007
End Date
December 1 2007
Last Update
March 29 2017
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