NCT01499758

A Bioequivalence Study Of 80 Mg Atorvastatin Calcium Tablets Versus 80 Mg Lipitor® Tablets Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study assessed the relative bioavailability of 80 mg Atorvastatin Calcium Tablets (containing atorvastatin calcium equivalent to 80 mg atorvastatin) manufactured by OHM Laboratories, Inc., USA (A subsidiary of Ranbaxy Pharmaceuticals., USA) compared to that of 80 mg LIPITOR® Tablets (containing atorvastatin calcium equivalent to 80 mg atorvastatin) distributed by Parke Davis, Division of Pfizer Inc., USA following a single oral dose (1 x 80 mg tablet) in healthy adult subjects when administered under fasting conditions.

Detailed description

This was an open-label, balanced, randomized, two-period, two-treatment, two-sequence, single-dose crossover bioequivalence study under fasting conditions. The total duration of the study, screening through study exit, was approximately 8 weeks with at least a 14-day washout period between doses. At study check-in, the subjects reported to the clinical site at least 36 hours prior to Day 1 dosing and were required to stay for 24 hours after Day 1 dosing. Blood sample collections were obtained within 90 minutes prior to dosing (0 hour) and after dose administration at 0.167, 0.25, 0.333, 0.417, 0.5, 0.583, 0.667, 0.833, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 60, 72, and 96 hours. A total of 30 blood samples were collected per study period for a total of 60 samples or 180 mL total volume.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Atorvastatin	80 Mg tablets

Timeline

• Start date: 2009-10-01
• Primary completion: 2009-10-01
• Completion: 2009-12-01
• First posted: 2011-12-26
• Last updated: 2012-07-10

Locations

1 site across 1 country: United States