NCT00974012

Divalproex Sodium 500 mg Extended Release Tablets Under Non-Fasting Conditions

A Relative Bioavailability Study of 500 mg Divalproex Sodium Extended Release Tablets Under Non-Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study was designed to compare the relative bioavailability (rate and extent of absorption) of Divalproex Sodium ER Tablets 500 mg with that of Depakote® ER Tablets 500 mg following a single, oral dose (1 x 500 mg extended release tablet) administered to healthy, adult subjects under non-fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Divalproex Sodium	500 mg ER Tablet
DRUG	Depakote®	500 mg ER Tablet

Timeline

• Start date: 2006-10-01
• Primary completion: 2006-10-01
• Completion: 2006-10-01
• First posted: 2009-09-10
• Last updated: 2009-09-10

Locations

1 site across 1 country: United States