Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00913848
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
Sandoz

Tracking Information
First Submitted Date  ICMJE June 2, 2009
First Posted Date  ICMJE June 4, 2009
Last Update Posted Date March 28, 2017
Study Start Date  ICMJE October 2005
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
Bioequivalence based on AUC and Cmax [ Time Frame: 10 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fed Conditions
Official Title  ICMJE A Single-Dose Comparative Bioavailability Study of Two Formulations of Divalproex Sodium 500 mg Delayed Release Tablets Under Fed Conditions
Brief Summary To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release tablets under fed conditions.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Epilepsy
  • Bipolar Disorder
Intervention  ICMJE
  • Drug: Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)
  • Drug: Depakote 500 mg DR Tablets (Abbott Laboratories, USA)
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2009)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2005
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 21 Years to 47 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00913848
Other Study ID Numbers  ICMJE 2005-1050
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Study Sponsor  ICMJE Sandoz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xueyu (Eric) Chen, M.D. Pharma Medica Research, Inc.
PRS Account Sandoz
Verification Date June 2009

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