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Bioequivalence Study Of Pediatric Appropriate Formulation

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NCT00758004

Last updated on August 9, 2018
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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypercholesterolemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and/or female volunteers

- Mass Index (BMI) of approximately 18 to 30 kg/m2

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Any condition possibly affecting drug absorption

- A positive urine drug screening

NCT00758004
Pfizer
Completed
Bioequivalence Study Of Pediatric Appropriate Formulation

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Bioequivalence Study Of Pediatric Appropriate Formulation
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
To determine bioequivalence of pediatric appropriate 80 mg atorvastatin formulation comparing to the 80 mg commercial atorvastatin calcium tablet formulation.
Determination of Bioequivalence
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Hypercholesterolemia
  • Drug: Atorvastatin
    A single dose of 80 mg atrovastatin tablet
  • Drug: Atorvastatin pediatric appropriate formulation
    A single dose of pediatric appropriate atorvastatin 80 mg formulation
    Other Name: Atorvastatin
  • Reference
    Commercial 80 mg atorvastatin tablet
    Intervention: Drug: Atorvastatin
  • Test
    Pediatric appropriate atorvastatin 40mg formulation
    Intervention: Drug: Atorvastatin pediatric appropriate formulation
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
March 2009
March 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00758004
A2581175
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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[email protected]



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