NCT01645384

Bioequivalence Study of Atorvastatin Calcium Tablets, 40 mg Under Fasting Conditions

An Open-label, Randomized, Single Oral Dose, Two Way Crossover Bioequivalence Study of Atorvastatin Ca 40 mg Tablets of Dr.Reddy's With Lipitor® 40 mg Tablets of Pfizer in 74 Healthy, Adult, Human Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (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 monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance of Atorvastatin formulations under fasting conditions.

Detailed description

An open-label, randomized, single oral dose, two way crossover bioequivalence study to compare Atorvastatin Calcium 40 mg Tablets of Dr.Reddy's with Lipitor® 40 mg Tablets of Pfizer in 74 healthy, adult, human study participants under fasting 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: 2009-05-01
• Primary completion: 2009-06-01
• Completion: 2009-07-01
• First posted: 2012-07-20
• Last updated: 2012-07-20

Locations

1 site across 1 country: India