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

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: Oxymorphone

• Registration Number: NCT00857428
• 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

Bioequivalence based on FDA Criteria.

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2007-11
• Study Completion: 2007-12
• Status Verified: 2009-03
• Study First Submitted: 2009-03-04
• 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: 50

Inclusion Criteria

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

Exclusion Criteria

• Positive test results for HIV or hepatitis B or C
• Treatment for drug or alcohol dependence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Oxymorphone	Oxymorphone ER 40 mg tablets Sandoz
2	Oxymorphone	Opana ER 40 mg tablets Eon Pharmaceuticals

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on Cmax and AUC	Four Weeks