NCT00758004

Bioequivalence Study Of Pediatric Appropriate Formulation

An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing A New 80 Mg (2x40 mg) Pediatric Appropriate Formulation To A 80 Mg Commercial Atorvastatin Calcium Tablet Formulation In Healthy Subjects

• Status: Completed
• Phase: Phase 1
• 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 bioequivalence of pediatric appropriate 80 mg atorvastatin formulation comparing to the 80 mg commercial atorvastatin calcium tablet formulation.

Detailed description

Determination of Bioequivalence

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Atorvastatin	A single dose of 80 mg atrovastatin tablet
DRUG	Atorvastatin pediatric appropriate formulation	A single dose of pediatric appropriate atorvastatin 80 mg formulation

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2008-09-23
• Last updated: 2021-02-18

Locations

1 site across 1 country: United States