NCT01645449

Bioequivalence Study of Atorvastatin Calcium Tablets, 80 mg of Dr. Reddy's Under Fasting Conditions

An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-way Crossover Oral BE Study of Atorvastatin Ca 80 mg Tablets of Dr. Reddy's and Lipitor 80 mg Tablets of Pfizer in Healthy Adult, Human Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare and evaluate the single-dose oral bioavailability and to monitor the safety of subjects.

Detailed description

An open label, balanced, randomized, two-treatment, two-period, two-way crossover oral bioequivalence' study of Atorvastatin Calcium 80 mg Tablets of Dr. Reddy's and Lipitor 80 mg Tablets of Pfizer Ireland Pharmaceuticals in healthy adult, human subjects under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Atorvastatin Calcium Tablets, 80 mg	Atorvastatin Calcium Tablets, 80 of Dr. Reddy's Laboratories Limited

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2012-07-20
• Last updated: 2012-07-20

Locations

1 site across 1 country: Germany