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Bioavailability Study for New Atorvastatin Formulation

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
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 subjects

- Body 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

NCT00844376
Pfizer
Completed
Bioavailability Study for New Atorvastatin Formulation

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Bioavailability Study for New Atorvastatin Formulation
An Open Label, Single Dose, Randomized 2-Way Crossover Study To Estimate The Relative Bioavailability Of Atorvastatin Commercial Tablet, And An Extemporaneous Preparation (EP) Suspension Formulation, In Healthy Subjects
The purpose of this study is to estimate the relative bioavailability of the commercial tablet with one prototype extemporaneous preparation suspension formulation, to assist with internal decision making on formulation development.
Estimation of Relative Bioavailability
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Hypercholesterolemia
  • Drug: Atorvastatin suspension
    A single dose of 80 mg Atorvastatin suspension
  • Drug: Lipitor
    A single dose of 80 mg Lipitor tablet
    Other Name: Atorvastatin
  • Test
    Extemporaneous preparation suspension Atorvastatin prototype formulation
    Intervention: Drug: Atorvastatin suspension
  • Reference
    Commercial atorvastatin tablet (Lipitor®)
    Intervention: Drug: Lipitor
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2008
March 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and/or female subjects
  • Body 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
 
 
NCT00844376
A2581164
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2009

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

BY EMAIL

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[email protected]



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