Bioequivalence Study On Pediatric Appropriate Formulation - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00777517

Purpose

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

Condition	Intervention	Phase
Hypercholesterolemia	Drug: Lipitor Drug: Atorvastatin pediatric formulation	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Calcium Cholesterol

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Primary study endpoints will be AUClast, AUCinf (if data permit) and Cmax from plasma atorvastatin concentration data. [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	76
Study Start Date:	November 2008
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Reference Commercial 10 mg Lipitor formulation tablet	Drug: Lipitor A single dose of 10 mg Lipitor tablet Other Name: Atorvastatin
Test Atorvastatin pediatric formulation	Drug: Atorvastatin pediatric formulation A single dose of 10 mg atorvastatin pediatric formulation

Detailed Description:

Determination of Bioequivalence

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777517

Locations

Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00777517 History of Changes
Other Study ID Numbers:	A2581174
Study First Received:	October 20, 2008
Last Updated:	August 26, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Cardiovascular Diseases

Additional relevant MeSH terms:

Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents

Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012