Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fed Conditions
Overview
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.
Full Title of Study: “A Study to Evaluate the Relative Bioavaility of Oxymorphone Hydrochloride 40 mg Extended-Release Tablets(Sandoz, Inc. Compared to Opana ER (Oxymorphone Hydrochloride) Extended-Release Tablets, 40 mg (Edo Pharmaceuticals Inc.) in Healthy Volunteers Under Non-fasted COnditions”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 2007
Interventions
- Drug: oxymorphone hydrochloride
- Drug: Opana
Arms, Groups and Cohorts
- Experimental: 1
- Oxymorphone hydrochloride 40 mg extended release tablets (Sandoz)
- Active Comparator: 2
- Opana 40 mg extended release tablets
Clinical Trial Outcome Measures
Primary Measures
- Bioequivalence according to US FDA guidelines
- Time Frame: Two weeks
Participating in This Clinical Trial
Inclusion Criteria
- No clinically significant abnormal findings on physical exam, nonmedical history or clinical laboratory results on screening. Exclusion Criteria:
- Positive test results for HIV or hepatitis B or C – Treatment for drug or alcohol abuse – Allergy to opiates
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 55 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Sandoz
- Provider of Information About this Clinical Study
- Eric Mittleberg, VP Product Development, Sandoz Inc.
- Overall Official(s)
- Daryl G. Ficklin, D.O., Principal Investigator, Novum Pharmaceutical Research Services
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