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Bioavailability Study for New Atorvastatin Formulation

Last updated on November 12, 2019

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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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Descriptive Information
Brief Title  ICMJE Bioavailability Study for New Atorvastatin Formulation
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionEstimation of Relative Bioavailability
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • Drug: Atorvastatin suspension
    A single dose of 80 mg Atorvastatin suspension
  • Drug: Lipitor
    A single dose of 80 mg Lipitor tablet
    Other Name: Atorvastatin
Study Arms  ICMJE
  • Test
    Extemporaneous preparation suspension Atorvastatin prototype formulation
    Intervention: Drug: Atorvastatin suspension
  • Reference
    Commercial atorvastatin tablet (Lipitor®)
    Intervention: Drug: Lipitor
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 13, 2009)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion DateMarch 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00844376
Other Study ID Numbers  ICMJE A2581164
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2009

ICMJE     Data element required by the

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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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