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.
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 study of Dr.Reddy's Divalproex Sodium Coated Particles in Capsules, 125 mg
Time frame: 4 months
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