NCT00917644

Bioequivalence Study Comparing A New 80 Mg Atorvastatin Tablet To A 80 Mg Atorvastatin Commercial Tablet

An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing A New 80 Mg Atorvastatin Tablet To A 80 Mg Atorvastatin Commercial Tablet In Healthy Subjects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To determine whether new 80 mg atorvastatin tablets are bioequivalent to 80 mg commercial atorvastatin tablets (Lipitor®).

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Atorvastatin	A single 80 mg dose of marketed 80 mg atorvastatin tablets
GENETIC	Atorvastatin	A single dose of new formulation of 80 mg atorvastatin tablets

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2009-06-10
• Last updated: 2021-02-21
• Results posted: 2009-10-15

Locations

1 site across 1 country: United States