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

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ClinicalTrials.gov Identifier: NCT00913874
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:

Study Description
Brief Summary:
To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release tablets under fasting conditions.

Condition or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : October 2005
Primary Completion Date : October 2005
Study Completion Date : October 2005


Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 10 days ]

Eligibility Criteria

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 Posted: June 4, 2009    Key Record Dates
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