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

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sandoz
• Treatments: Valproic Acid

Criteria

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