NCT01132040

Bioequivalence Study of Primidone Tablets 50 mg of Dr. Reddy's 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 Comparing With That of Mysoline® 50 mg Tablets Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Primidone	Primidone Tablets, USP 50 mg of Dr. Reddy's Laboratories Limited

Timeline

• Start date: 2006-08-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2010-05-27
• Last updated: 2010-05-27

Locations

1 site across 1 country: India