NCT01132183

Bioequivalence Study of Divalproex Sodium Capsules(Sprinkle),125 mg of Dr. Reddy's Under Fasting Condition (Apple Sauce)

An Open Label, Balanced, Randomized, Two-treatment, Single-dose, Crossover, Bioequivalence Study of Divalproex Sodium Coated Particles in Capsules, 125 mg With Depakote® Sprinkle 125 mg in Healthy Human Subjects Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study of Divalproex Sodium coated particles in capsules 125 mg with Depakote® Sprinkle125 mg capsules in healthy, adult, human subjects under fasting conditions.

Detailed description

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study of Divalproex Sodium Capsules (Sprinkle), 125 mg of Dr.Reddy's Laboratories Limited,comparing with that of Depakote® Sprinkle 125 mg capsules of Abbott Laboratories, USA in healthy, adult, human subjects under fasting conditions with an adequate washout period of 10 days. The subjects were given a single oral dose of medication (test study or reference medication) . The capsule was opened and all the contents were sprinkled over a spoonful of applesauce without a spillage and administered to the subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Divalproex Sodium	Divalproex Sodium Coated Particles in Capsules, 125 mg of Dr. Reddy's Laboratories Limited

Timeline

• Start date: 2007-02-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2010-05-27
• Last updated: 2010-05-27

Locations

1 site across 1 country: India