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Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fed Conditions

Information source: Sandoz
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: oxymorphone hydrochloride (Drug); Opana (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Sandoz Inc.

Official(s) and/or principal investigator(s):
Daryl G. Ficklin, D.O., Principal Investigator, Affiliation: Novum Pharmaceutical Research Services

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.

Clinical Details

Official title: 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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bioequivalence according to US FDA guidelines

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: November 2007
Last updated: March 5, 2009

Page last updated: August 23, 2015

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