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Bioequivalence Study of Primidone Tablets 50 mg of Dr. Reddy's Under Fasting Conditions

2014-08-27 03:13:22 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Healthy

Intervention

Primidone

Location

Bioserve Clinical Research Pvt. Ltd,
HYD
Andhra Pradesh
India
500 037

Status

Completed

Source

Dr. Reddy's Laboratories Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:22-0400

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