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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00777517

Enrollment

Registered

2008-10-22

Start date

2008-11-30

Completion date

2009-02-28

Last updated

2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

Cardiovascular Diseases

Brief summary

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

Detailed description

Determination of Bioequivalence

Interventions

DRUGLipitor

A single dose of 10 mg Lipitor tablet

DRUGAtorvastatin pediatric formulation

A single dose of 10 mg atorvastatin pediatric formulation

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026