Bioequivalence Study of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions

Phase 1

Completed

• Conditions: Seizures
• Interventions: Drug: Divalproex Sodium; Drug: Depakote DR Tablets

• Registration Number: NCT00864006
• Lead Sponsor: Sandoz

Brief Summary

The purpose of this study is to demonstrate the bioequivalence of divalproex sodium 125 MG delayed release tablets.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2009-03
• Study First Submitted: 2009-03-17
• Study First Submitted QC: 2009-03-17
• Study First Posted: 2009-03-18
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

Inclusion Criteria

• No clinically significant findings on physical examination, medical history or laboratory tests on screening

Exclusion Criteria

• Positive test for HIV or Hepatitis B and C
• History of sensitivity to valproic acid or related compounds

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Divalproex Sodium	Divalproex Sodium 125 MG Delayed Release Tablets Sandoz
2	Depakote DR Tablets	Depakote 125 MG DR Tablets Abbott Laboratories USA

Primary Outcome Measures

Name	Time	Method
Bioequivalence according to US FDA Guidelines	9 Days