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

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00857142
First received: March 5, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted

March 5, 2009
March 5, 2009
November 2007
December 2007   (final data collection date for primary outcome measure)
Bioequivalence according to US FDA guidelines [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
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Not Provided
 
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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00857142
10713410
Not Provided
Eric Mittleberg, VP Product Development, Sandoz Inc.
Sandoz Inc.
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