NCT00647712

Fasting Study of Divalproex Sodium Extended-Release Tablets 500 mg to Depakote ER® Tablets 500 mg

Single-Dose Fasting In Vivo Bioequivalence Study of Divalproex Sodium Extended-Release Tablets (500 mg; Mylan) to Depakote ER® Tablets (500 mg; Abbott) in Healthy, Adult Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Divalproex Sodium Extended-Release Tablets 500 mg	500mg, single dose fasting
DRUG	Depakote ER® Tablets 500 mg	500mg, single dose fasting

Timeline

• Start date: 2004-12-01
• Primary completion: 2004-12-01
• Completion: 2004-12-01
• First posted: 2008-04-01
• Last updated: 2009-09-25

Locations

1 site across 1 country: United States