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

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: oxymorphone hydrochloride; Drug: Opana

• Registration Number: NCT00857142
• Lead Sponsor: Sandoz

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

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2009-03
• Study First Submitted: 2009-03-05
• Study First Submitted QC: 2009-03-05
• Study First Posted: 2009-03-06
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	oxymorphone hydrochloride	Oxymorphone hydrochloride 40 mg extended release tablets (Sandoz)
2	Opana	Opana 40 mg extended release tablets

Primary Outcome Measures

Name	Time	Method
Bioequivalence according to US FDA guidelines	Two weeks