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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
  Purpose
To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release tablets under fasting 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
Intervention Model: Crossover Assignment
Masking: None (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 Fasting 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913874


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

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00913874     History of Changes
Other Study ID Numbers: 2005-1049
First Submitted: June 2, 2009
First Posted: June 4, 2009
Last Update Posted: March 28, 2017
Last Verified: June 2009

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Valproic Acid
Anticonvulsants
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