NCT00857428
Completed
Phase 1
A Study to Evaluate the Relative Bioavailability of Oxymorphone 40 mg Extended-Release Tablets (Sandoz, Inc.) Compared to Opana ER (Oxymorphone Hydrochloride) Extended-Release Tablets, 40 mg (Endo Pharmaceuticals, Inc.) in Healthy Volunteers Under Fasted Conditions
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Sandoz
- Enrollment
- 50
- Primary Endpoint
- Bioequivalence based on Cmax and AUC
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •No clinically significant abnormal findings on physical exam, medical history or clinical laboratory results on screening.
Exclusion Criteria
- •Positive test results for HIV or hepatitis B or C
- •Treatment for drug or alcohol dependence
Arms & Interventions
1
Experimental
Oxymorphone ER 40 mg tablets Sandoz
Intervention: Oxymorphone (Drug)
2
Active Comparator
Opana ER 40 mg tablets Eon Pharmaceuticals
Intervention: Oxymorphone (Drug)
Outcomes
Primary Outcomes
Bioequivalence based on Cmax and AUC
Time Frame: Four Weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
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