NCT01167894

Bioequivalence Study of Simvastatin Tablets 80 mg of Dr. Reddy's Under Fasting Condition

A Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioequivalence Study of Simvastatin 80 mg Tablets of Dr. Reddy's to be Compared With Zocor® 80 mg Tablets of Merck & Co. Inc., USA in Healthy Adult Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to * compare the single dose bioavailability of Simvastatin 80 mg tablets with Zocor® 80 mg tablets of MercK \& Co. Inc, USA in healthy subjects under fasting conditions * monitor adverse events and to ensure the safety of subjects.

Detailed description

A randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study of Simvastatin 80mg tablets of Dr. Reddy's Laboratories Limited to be compared with Zocor® 80 mg tablets of Merck \& Co. Inc., USA in healthy, adult, human subjects under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Simvastatin	Simvastatin 80 mg tablets Dr. Reddy's Laboratories Ltd

Timeline

• Start date: 2005-01-01
• Primary completion: 2005-04-01
• Completion: 2005-04-01
• First posted: 2010-07-22
• Last updated: 2010-07-22