NCT01581788

Bioequivalence Study of Divalproex Sodium ER Tablets, 500 mg Under Fed Conditions

Open Label, Balanced, Randomized, Single-dose, Crossover Oral Bioequivalence Study of Divalproex Sodium ER Tablets 500 mg of Dr. Reddy's and Depakote ER 500 mg Tablets of Abbott Laboratories, in Healthy Subjects Under Fed Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the bioequivalence between Divalproex Sodium ER Tablets 500 mg of Dr. Reddy's and Depakote ER 500 mg Tablets of Abbott Laboratories in healthy, adult, human subjects, under fed conditions and to monitor adverse events and ensure the safety of subjects.

Detailed description

Open label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose, crossover oral bioequivalence study of Divalproex Sodium Extended Release Tablets 500 mg of Dr. Reddy's Laboratories Limited, and Depakote ER 500 mg mg Tablets of Abbott Laboratories in healthy, adult, human subjects, under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Divalproex Sodium	Divalproex Sodium ER Tablets, 500 mg

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-02-01
• Completion: 2011-03-01
• First posted: 2012-04-20
• Last updated: 2012-04-20

Locations

1 site across 1 country: India