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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00857142
First Posted: March 6, 2009
Last Update Posted: March 29, 2017
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.
Information provided by:
Sandoz
March 5, 2009
March 6, 2009
March 29, 2017
November 2007
December 2007   (Final data collection date for primary outcome measure)
Bioequivalence according to US FDA guidelines [ Time Frame: Two weeks ]
Same as current
Complete list of historical versions of study NCT00857142 on ClinicalTrials.gov Archive Site
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Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fed Conditions
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pain
  • Drug: oxymorphone hydrochloride
  • Drug: Opana
  • Experimental: 1
    Oxymorphone hydrochloride 40 mg extended release tablets (Sandoz)
    Intervention: Drug: oxymorphone hydrochloride
  • Active Comparator: 2
    Opana 40 mg extended release tablets
    Intervention: Drug: Opana
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
December 2007
December 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00857142
10713410
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Eric Mittleberg, VP Product Development, Sandoz Inc.
Sandoz
Not Provided
Principal Investigator: Daryl G. Ficklin, D.O. Novum Pharmaceutical Research Services
Sandoz
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP