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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Divalproex Sodium Coated Particles in Capsules, 125 mg of Dr. Reddy's Laboratories Limited
Bioserve Clinical Research Pvt. Ltd.
Hyd, Andhra Pradesh, India
Bioequivalence based on Cmax and AUC parameters
Time frame: 2 months
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