NCT01184391

Bioequivalence Study of Divalproex Sodium Delayed-Release Tablets, 500 mg

Single-Dose Fasting Bioequivalence Study of Divalproex Sodium Delayed-Release Tablets (500 mg; Mylan) and Depakote Tablets (500 mg; Abbott) in Healthy Adult Male And Female (Not of Childbearing Potential) Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to investigate the bioequivalence of Mylan's divalproex sodium-delayed-release tablets 500 mg tablets to Abbott's Depakote® 500 mg tablets following a single, oral 500 mg (1 x 500 mg) dose administration under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	DEPAKOTE® Tablets, 500 MG	1 x 500 mg tablet, under fasting conditions
DRUG	DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG	1 X 500 mg Tablet, under fasting conditions.

Timeline

• Start date: 2007-07-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2010-08-18
• Last updated: 2010-08-18

Locations

1 site across 1 country: United States