Bioequivalence Study Of Pediatric Appropriate Formulation

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.76 enrolled

Overview

To determine bioequivalence of pediatric appropriate 80 mg atorvastatin formulation comparing to the 80 mg commercial atorvastatin calcium tablet formulation.

Determination of Bioequivalence

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hypercholesterolemia

Interventions

AtorvastatinDRUG

A single dose of 80 mg atrovastatin tablet

Atorvastatin pediatric appropriate formulationDRUG

A single dose of pediatric appropriate atorvastatin 80 mg formulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

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

Time frame: 5 months

Secondary Outcomes

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.

Time frame: 5 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.