Bioequivalence Study On Pediatric Appropriate Formulation

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

Overview

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

Determination of Bioequivalence

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hypercholesterolemia

Interventions

LipitorDRUG

A single dose of 10 mg Lipitor tablet

Atorvastatin pediatric formulationDRUG

A single dose of 10 mg atorvastatin pediatric formulation

Eligibility

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

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

Singapore, Singapore

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

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