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

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00913848
First received: June 2, 2009
Last updated: June 3, 2009
Last verified: June 2009
  Purpose

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


Condition Intervention Phase
Epilepsy
Bipolar Disorder
Drug: Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)
Drug: Depakote 500 mg DR Tablets (Abbott Laboratories, USA)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-Dose Comparative Bioavailability Study of Two Formulations of Divalproex Sodium 500 mg Delayed Release Tablets Under Fed Conditions

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: October 2005
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)
Drug: Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)
Active Comparator: 2
Depakote 500 mg DR Tablets (Abbott Laboratories, USA)
Drug: Depakote 500 mg DR Tablets (Abbott Laboratories, USA)

  Eligibility

Ages Eligible for Study:   21 Years to 47 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913848

Sponsors and Collaborators
Sandoz Inc.
Investigators
Principal Investigator: Xueyu (Eric) Chen, M.D. Pharma Medica Research Inc.
  More Information

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00913848     History of Changes
Other Study ID Numbers: 2005-1050
Study First Received: June 2, 2009
Last Updated: June 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Sandoz:
Treatment of Epilepsy and Bipolar Disorder

Additional relevant MeSH terms:
Bipolar Disorder
Epilepsy
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 23, 2014