Bioequivalency Study of Oxymorphone Hydrochloride 10 mg Tablets Under Fasted Conditions

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: Oxymorphone

• Registration Number: NCT01210638
• Lead Sponsor: Roxane Laboratories

Brief Summary

The objective of this study was to prove the bioequivalence of Oxymorphone Hydrochloride 10 mg Tablets under fasting conditions

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2010-09-27
• Study First Submitted QC: 2010-09-27
• Study First Posted: 2010-09-28
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria

• Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to oxymorphone hydrochloride or any comparable or similar product.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oxymorphone Hydrochloride	Oxymorphone	Tablet
Opana	Oxymorphone	Tablet

Primary Outcome Measures

Name	Time	Method
bioequivalence determined by statistical comparison Cmax	9 days

Trial Locations

Locations (1)

Novum Pharmaceutical Research Services; 🇺🇸 Houston, Texas, United States