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Bioequivalence Study On Pediatric Appropriate Formulation

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ClinicalTrials.gov Identifier: NCT00777517
Recruitment Status : Completed
First Posted : October 22, 2008
Last Update Posted : August 27, 2009
Sponsor:
Information provided by:
Pfizer

Study Description
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Brief Summary:
To determine bioequivalence of a atorvastatin pediatric formulation comparing to the 10 mg commercial atorvastatin calcium tablet formulation.

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

Detailed Description:
Determination of Bioequivalence
Study Design
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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 Pediatric Appropriate Formulation To A 10 Mg Commercial Atorvastatin Calcium Tablet Formulation In Healthy Subjects
Study Start Date : November 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00777517


Locations
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Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00777517    
Other Study ID Numbers: A2581174
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: August 27, 2009
Last Verified: February 2009
Keywords provided by Pfizer:
Cardiovascular Diseases
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors