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

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ClinicalTrials.gov Identifier: NCT00857428
Recruitment Status : Completed
First Posted : March 6, 2009
Last Update Posted : March 29, 2017
Information provided by:

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 Drug: Oxymorphone Phase 1

Detailed Description:
Bioequivalence based on FDA Criteria.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : November 2007
Primary Completion Date : November 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Oxymorphone ER 40 mg tablets Sandoz
Drug: oxymorphone
Other Name: Opana
Active Comparator: 2
Opana ER 40 mg tablets Eon Pharmaceuticals
Drug: Oxymorphone
40 mg tablets
Other Name: Opana

Primary Outcome Measures :
  1. Bioequivalence based on Cmax and AUC [ Time Frame: Four Weeks ]

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

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

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): NCT00857428

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

Responsible Party: Eric Mittleberg, Ph.D, VP Product Development, Sandoz
ClinicalTrials.gov Identifier: NCT00857428     History of Changes
Other Study ID Numbers: 10713409
First Posted: March 6, 2009    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2009

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