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The purpose of this study is to assess the bioavailability of Primidone 50 mg tablets of Dr.Reddy's comparing with that of Mysoline@ tablets of Yamanouchi Pharma Technologies Inc, 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 Primidone 50 mg tablets of Dr.Reddy's Laboratories Limited, Generics, India comparing with that of Mysoline (containing Primidone 50 mg) tablets of Yamanouchi Pharma Technologies Inc, Norman, OK in healthy, adult, human subjects under fasting conditions with a washout period of 14 days.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Bioserve Clinical Research Pvt. Ltd,
Dr. Reddy's Laboratories Limited
Published on BioPortfolio: 2014-08-27T03:13:22-0400
The purpose of this study is to compare the bioequivalence of a test formulation of primidone tablets to an equivalent oral dose of the commercially available Mysoline®(primidone tablets)...
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A metabolite of primidone.
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