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

Phase 1

Completed

• Conditions: Epilepsy; Bipolar Disorder
• Interventions: Drug: Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA); Drug: Depakote 500 mg DR Tablets (Abbott Laboratories, USA)

• Registration Number: NCT00913874
• Lead Sponsor: Sandoz

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Status Verified: 2009-06
• Study First Submitted: 2009-06-02
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)	Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)
2	Depakote 500 mg DR Tablets (Abbott Laboratories, USA)	Depakote 500 mg DR Tablets (Abbott Laboratories, USA)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	10 days