NCT00974441

Divalproex Sodium 500 mg Extended Release Tablets Under Fasting Conditions

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study will compare the relative bioavailability (rate and extent of absorption) of 500 mg Divalproex Sodium (equivalent to 500 mg Valproic Acid) Extended Release Tablets with that of Depakote® ER Tablets following a single oral dose (1 x 500 mg tablet) in healthy adult subjects administered under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Divalproex Sodium	500 mg Extended Release Tablet
DRUG	Depakote®	500 mg Extended Release Tablet

Timeline

• Start date: 2006-08-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2009-09-10
• Last updated: 2009-09-10

Locations

1 site across 1 country: United States