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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00857142
Recruitment Status : Completed
First Posted : March 6, 2009
Last Update Posted : March 29, 2017
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Pain Drug: oxymorphone hydrochloride Drug: Opana Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Relative Bioavaility of Oxymorphone Hydrochloride 40 mg Extended-Release Tablets(Sandoz, Inc. Compared to Opana ER (Oxymorphone Hydrochloride) Extended-Release Tablets, 40 mg (Edo Pharmaceuticals Inc.) in Healthy Volunteers Under Non-fasted COnditions
Study Start Date : November 2007
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Oxymorphone hydrochloride 40 mg extended release tablets (Sandoz)
Drug: oxymorphone hydrochloride
Active Comparator: 2
Opana 40 mg extended release tablets
Drug: Opana


Outcome Measures

Primary Outcome Measures :
  1. Bioequivalence according to US FDA guidelines [ Time Frame: Two weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00857142


Sponsors and Collaborators
Sandoz
Investigators
Principal Investigator: Daryl G. Ficklin, D.O. Novum Pharmaceutical Research Services
More Information

Responsible Party: Eric Mittleberg, VP Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00857142     History of Changes
Other Study ID Numbers: 10713410
First Posted: March 6, 2009    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2009

Additional relevant MeSH terms:
Oxymorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia