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

March 4, 2009
March 5, 2009
November 2007
November 2007   (final data collection date for primary outcome measure)
Bioequivalence based on Cmax and AUC [ Time Frame: Four Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00857428 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fasted Conditions
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

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.

Bioequivalence based on FDA Criteria.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
  • Drug: oxymorphone
    Tablets
    Other Name: Opana
  • Drug: Oxymorphone
    40 mg tablets
    Other Name: Opana
  • Experimental: 1
    Oxymorphone ER 40 mg tablets Sandoz
    Intervention: Drug: oxymorphone
  • Active Comparator: 2
    Opana ER 40 mg tablets Eon Pharmaceuticals
    Intervention: Drug: Oxymorphone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2007
November 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00857428
10713409
No
Eric Mittleberg, Ph.D, VP Product Development, Sandoz
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