Bioequivalence Study Of Pediatric Appropriate Formulation - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00758004

Purpose

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

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

Study Type:	Interventional
Study Design:	Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing A New 80 Mg (2x40 mg) Pediatric Appropriate Formulation To A 80 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:	October 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Reference Commercial 80 mg atorvastatin tablet	Drug: Atorvastatin A single dose of 80 mg atrovastatin tablet
Test Pediatric appropriate atorvastatin 40mg formulation	Drug: Atorvastatin pediatric appropriate formulation A single dose of pediatric appropriate atorvastatin 80 mg 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 volunteers
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: NCT00758004

Locations

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511

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

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A2581175
Study First Received:	September 22, 2008
Last Updated:	November 16, 2009
ClinicalTrials.gov Identifier:	NCT00758004 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Cardiovascular Diseases

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010