Divalproex Sodium Delayed-Release Tablets Under Non-Fasting Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: divalproex sodium; Drug: Depakote®

• Registration Number: NCT00834990
• Lead Sponsor: Teva Pharmaceuticals USA

Brief 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

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2003-09
• Study Completion: 2003-09
• Study First Submitted: 2009-01-30
• Study First Submitted QC: 2009-01-30
• Study First Posted: 2009-02-03
• Results First Submitted: 2009-06-22
• Results First Submitted QC: 2009-06-22
• Status Verified: 2009-08
• Results First Posted: 2009-08-04
• Last Update Submitted: 2009-08-14
• Last Update Posted: 2009-08-20

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
1	divalproex sodium	-
2	Depakote®	-

Primary Outcome Measures

Name	Time	Method
Cmax (Maximum Observed Concentration)	Blood samples collected over a 72 hour period.	Bioequivalence based on Cmax.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)	Blood samples collected over a 72 hour period.	Bioequivalence based on AUC0-t.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)	Blood samples collected over a 72 hour period.	Bioequivalence based on AUC0-inf.

Trial Locations

Locations (1)

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