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Bioequivalence Study Of Pediatric Appropriate Formulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00758004
Recruitment Status : Completed
First Posted : September 23, 2008
Last Update Posted : November 18, 2009
Information provided by:

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

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Atorvastatin Drug: Atorvastatin pediatric appropriate formulation Phase 1

Detailed Description:
Determination of Bioequivalence

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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
Study Start Date : October 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Commercial 80 mg atorvastatin tablet
Drug: Atorvastatin
A single dose of 80 mg atrovastatin tablet

Pediatric appropriate atorvastatin 40mg formulation
Drug: Atorvastatin pediatric appropriate formulation
A single dose of pediatric appropriate atorvastatin 80 mg formulation
Other Name: Atorvastatin

Primary Outcome Measures :
  1. Primary study endpoints will be AUClast, AUCinf (if data permit) and Cmax from plasma atorvastatin concentration data. [ Time Frame: 5 months ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00758004

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United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00758004     History of Changes
Other Study ID Numbers: A2581175
First Posted: September 23, 2008    Key Record Dates
Last Update Posted: November 18, 2009
Last Verified: March 2009

Keywords provided by Pfizer:
Cardiovascular Diseases

Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors