Skip to main content
OpenTrials
Completed

NCT Number: NCT00857428

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

Bioequivalence based on FDA Criteria.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxymorphone

Drug

Tablets

Other names: Opana

Primary outcomes

  1. Bioequivalence based on Cmax and AUC

    Time frame: Four Weeks

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

A Study to Evaluate the Relative Bioavailability of Oxymorphone 40 mg Extended-Release Tablets (Sandoz, Inc.) Compared to Opana ER (Oxymorphone Hydrochloride) Extended-Release Tablets, 40 mg (Endo Pharmaceuticals, Inc.) in Healthy Volunteers Under Fasted Conditions

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Mar 6, 2009
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.