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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