NCT00777517

Bioequivalence Study On Pediatric Appropriate Formulation

An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing A Pediatric Appropriate Formulation To A 10 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 a atorvastatin pediatric formulation comparing to the 10 mg commercial atorvastatin calcium tablet formulation.

Detailed description

Determination of Bioequivalence

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Lipitor	A single dose of 10 mg Lipitor tablet
DRUG	Atorvastatin pediatric formulation	A single dose of 10 mg atorvastatin pediatric formulation

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-10-22
• Last updated: 2021-02-18

Locations

1 site across 1 country: Singapore