Bioequivalence Study Of Pediatric Appropriate Formulation

Phase 1

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: Atorvastatin pediatric appropriate formulation; Drug: Atorvastatin

• Registration Number: NCT00758004
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief 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

Study Timeline

• Study First Submitted: 2008-09-22
• Study First Submitted QC: 2008-09-22
• Study First Posted: 2008-09-23
• Study Start: 2008-10
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Healthy male and/or female volunteers
• Mass Index (BMI) of approximately 18 to 30 kg/m2

Exclusion Criteria

• Any condition possibly affecting drug absorption
• A positive urine drug screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test	Atorvastatin pediatric appropriate formulation	Pediatric appropriate atorvastatin 40mg formulation
Reference	Atorvastatin	Commercial 80 mg atorvastatin tablet

Primary Outcome Measures

Name	Time	Method
Primary study endpoints will be AUClast, AUCinf (if data permit) and Cmax from plasma atorvastatin concentration data.	5 months

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints will include Tmax and t1/2 (if data permit) of atorvastatin ; AUClast, AUCinf, Cmax, Tmax, and t1/2 (if data permit) of o-hydroxyatorvastatin and p-hydroxyatorvastatin.	5 months

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States