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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00913874
First Posted: June 4, 2009
Last Update Posted: March 28, 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
June 2, 2009
June 4, 2009
March 28, 2017
October 2005
October 2005   (Final data collection date for primary outcome measure)
Bioequivalence based on AUC and Cmax [ Time Frame: 10 days ]
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
Intervention Model: Crossover Assignment
Masking: None (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)
Not Provided

*   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.
Sexes Eligible for Study: Male
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00913874
2005-1049
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Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz
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