Status:

COMPLETED

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

Eligibility Criteria

Inclusion

  • No clinically significant abnormal findings on physical exam, nonmedical history or clinical laboratory results on screening.

Exclusion

  • Positive test results for HIV or hepatitis B or C
  • Treatment for drug or alcohol abuse
  • Allergy to opiates

Key Trial Info

Start Date :

November 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2007

Estimated Enrollment :

32 Patients enrolled

Trial Details

Trial ID

NCT00857142

Start Date

November 1 2007

End Date

December 1 2007

Last Update

March 29 2017

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