To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00913874
First received: June 2, 2009
Last updated: June 3, 2009
Last verified: June 2009

June 2, 2009
June 3, 2009
October 2005
October 2005   (final data collection date for primary outcome measure)
Bioequivalence based on AUC and Cmax [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00913874 on ClinicalTrials.gov Archive Site
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To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fasting Conditions
A Single-Dose Comparative Bioavailability Study of Two Formulations of Divalproex Sodium 500 mg Delayed Release Tablets Under Fasting Conditions

To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release tablets under fasting conditions.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Epilepsy
  • Bipolar Disorder
  • Drug: Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)
  • Drug: Depakote 500 mg DR Tablets (Abbott Laboratories, USA)
  • Experimental: 1
    Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)
    Intervention: Drug: Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)
  • Active Comparator: 2
    Depakote 500 mg DR Tablets (Abbott Laboratories, USA)
    Intervention: Drug: Depakote 500 mg DR Tablets (Abbott Laboratories, USA)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2005
October 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • No clinically significant abnormal finding 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.
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00913874
2005-1049
Not Provided
Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz Inc.
Not Provided
Principal Investigator: Xueya (Eric) Chen, M.D. Pharma Medica Research Inc.
Sandoz
June 2009

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