NCT01645410

Bioequivalence Study of Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Under Fed Conditions

Open-label, Balanced, Randomized, Two-treatment, Two-sequence, Two-period, Single Oral Dose, Crossover BE Study of Atorvastatin Ca 40mg Tablets of Dr.Reddy's With Lipitor® 40 mg Tablets of Pfizer in Healthy Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 71 (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 assess the bioequivalence between Atorvastatin calcium 40 mg of Dr. Reddy's Laboratories Limited, India and Lipitor® 40mg Tablets of Pfizer Ireland Pharmaceuticals in healthy, adult, human subjects under fed condition.

Detailed description

Open-label, balanced, randomized, two-treatment, two-sequence,two-period, single-dose, crossover oral bioequivalence study of Atorvastatin calcium 40 mg Tablets of Dr. Reddy's Laboratories Limited, India and Lipitor® 40 mg Tablets of Pfizer Ireland Pharmaceuticals in healthy, adult, human subjects under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Atorvastatin Calcium Tablets, 40 mg	Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Laboratories Limited

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-04-01
• Completion: 2009-05-01
• First posted: 2012-07-20
• Last updated: 2012-07-20

Locations

1 site across 1 country: India