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Trial record 1 of 1 for:    NCT00777517
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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

Tracking Information
First Submitted Date  ICMJE October 20, 2008
First Posted Date  ICMJE October 22, 2008
Last Update Posted Date August 27, 2009
Study Start Date  ICMJE November 2008
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2008)
Primary study endpoints will be AUClast, AUCinf (if data permit) and Cmax from plasma atorvastatin concentration data. [ Time Frame: 5 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00777517 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study On Pediatric Appropriate Formulation
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • Drug: Lipitor
    A single dose of 10 mg Lipitor tablet
    Other Name: Atorvastatin
  • Drug: Atorvastatin pediatric formulation
    A single dose of 10 mg atorvastatin pediatric formulation
Study Arms  ICMJE
  • Reference
    Commercial 10 mg Lipitor formulation tablet
    Intervention: Drug: Lipitor
  • Test
    Atorvastatin pediatric formulation
    Intervention: Drug: Atorvastatin pediatric formulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2009)
76
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2008)
74
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00777517
Other Study ID Numbers  ICMJE A2581174
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP