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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Divalproex Sodium; Drug: Depakote®

• Registration Number: NCT00974012
• Lead Sponsor: Teva Pharmaceuticals USA

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2009-09
• Study First Submitted: 2009-09-09
• Study First Submitted QC: 2009-09-09
• Last Update Submitted: 2009-09-09
• Study First Posted: 2009-09-10
• Last Update Posted: 2009-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Divalproex Sodium	Divalproex Sodium	500 mg Extended Release Tablet
Depakote®	Depakote®	500 mg Extended Release Tablet

Primary Outcome Measures

Name	Time	Method
Cmax - Maximum Observed Concentration	Blood samples collected over 72 hour period
AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)	Blood samples collected over 72 hour period
AUC0-t - Area under the concentration-time curve from time zero to time of last quantifiable concentration (per participant)	Blood samples collected over 72 hour period

Trial Locations

Locations (1)

PRACS Institute, Ltd.; 🇺🇸 East Grand Forks, Minnesota, United States