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Bioequivalence Study Of Pediatric Appropriate Formulation

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00758004
Collaborator
(none)
76
Enrollment
1
Location
2
Arms
5
Duration (Months)
15.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine bioequivalence of pediatric appropriate 80 mg atorvastatin formulation comparing to the 80 mg commercial atorvastatin calcium tablet formulation.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Determination of Bioequivalence

Study Design

Study Type:
Interventional
Actual Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
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
Study Start Date :
Oct 1, 2008
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
Mar 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Other: Reference

Commercial 80 mg atorvastatin tablet

Drug: Atorvastatin
A single dose of 80 mg atrovastatin tablet
Other: Test

Pediatric appropriate atorvastatin 40mg formulation

Drug: Atorvastatin pediatric appropriate formulation
A single dose of pediatric appropriate atorvastatin 80 mg formulation
Other Names:
  • Atorvastatin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Primary study endpoints will be AUClast, AUCinf (if data permit) and Cmax from plasma atorvastatin concentration data. [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. [5 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site New Haven Connecticut United States 06511

    Sponsors and Collaborators

    • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
    ClinicalTrials.gov Identifier:
    NCT00758004
    Other Study ID Numbers:
    • A2581175
    First Posted:
    Sep 23, 2008
    Last Update Posted:
    Feb 18, 2021
    Last Verified:
    Feb 1, 2021
    Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
    Cardiovascular Diseases
    Additional relevant MeSH terms:
    Hypercholesterolemia
    Atorvastatin

    Study Results

    No Results Posted as of Feb 18, 2021