Bioequivalence Study On Pediatric Appropriate Formulation

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine bioequivalence of a atorvastatin pediatric formulation comparing to the 10 mg commercial atorvastatin calcium tablet formulation.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• Healthy male and/or female subjects

• Mass Index (BMI) of approximately 18 to 30 kg/m2

Exclusion Criteria:

• Any condition possibly affecting drug absorption

• A positive urine drug screening