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

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00857428
First received: March 4, 2009
Last updated: March 5, 2009
Last verified: March 2009
History of Changes
  Purpose

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 Intervention Phase
Pain
 Drug: oxymorphone
Drug: Oxymorphone
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on Cmax and AUC [ Time Frame: Four Weeks ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: November 2007
Study Completion Date: December 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oxymorphone ER 40 mg tablets Sandoz
 Drug: oxymorphone
Tablets
Other Name: Opana
Active Comparator: 2
Opana ER 40 mg tablets Eon Pharmaceuticals
 Drug: Oxymorphone
40 mg tablets
Other Name: Opana

Detailed Description:

Bioequivalence based on FDA Criteria.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857428

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

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP Product Development, Sandoz
ClinicalTrials.gov Identifier: NCT00857428     History of Changes
Other Study ID Numbers: 10713409
Study First Received: March 4, 2009
Last Updated: March 5, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013