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

March 27, 2017 updated by: Sandoz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Bioequivalence based on FDA Criteria.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Oxymorphone ER 40 mg tablets Sandoz
Drug: oxymorphone
Tablets
Other Names:
  • Opana
ACTIVE_COMPARATOR: 2
Opana ER 40 mg tablets Eon Pharmaceuticals
Drug: Oxymorphone
40 mg tablets
Other Names:
  • Opana

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bioequivalence based on Cmax and AUC
Time Frame: Four Weeks
Four Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandoz

Investigators

  • Principal Investigator: Daryl G. Ficklin, D.O., Novum Pharmaceutical Research Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (ACTUAL)

November 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

March 4, 2009

First Submitted That Met QC Criteria

March 5, 2009

First Posted (ESTIMATE)

March 6, 2009

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10713409

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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