Divalproex Sodium 500 mg Extended Release Tablets Under Fasting Conditions

Phase 1

Completed

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

• Registration Number: NCT00974441
• Lead Sponsor: Teva Pharmaceuticals USA

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2006-09
• Study Completion: 2006-09
• 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: 48

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-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
AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)	Blood samples collected over 72 hour period

Trial Locations

Locations (1)

PRACS Institute, Ltd.; 🇺🇸 Fargo, North Dakota, United States