NCT00834990

Divalproex Sodium Delayed-Release Tablets Under Non-Fasting Conditions

A Relative Bioavailability Study of 500 mg Divalproex Sodium Delayed-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 – 65 Years
• Healthy volunteers: Accepted

Summary

This study will compare the relative bioavailability of 500 mg Divalproex Sodium Delayed-Release Tablets with that of 500 mg Depakote® Tablets following a single oral dose (1 x 500 mg tablets) in healthy subjects under non-fasting conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	divalproex sodium	delayed-release 500 mg tablet
DRUG	Depakote®	delayed-release 500 mg tablet

Timeline

• Start date: 2003-09-01
• Primary completion: 2003-09-01
• Completion: 2003-09-01
• First posted: 2009-02-03
• Last updated: 2009-08-20
• Results posted: 2009-08-04

Locations

1 site across 1 country: United States