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A Bioequivalence Study Of 4 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00902187
Collaborator
(none)
36
Enrollment
1
Location
2
Arms
1
Duration (Months)
35.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To demonstrate bioequivalence of fesoterodine 4 mg tablets manufactured at Vega Baja, versus Zwickau.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
36 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 Of 4 Mg Fesoterodine Extended-Release Tablets (Toviaz™), Manufactured At Zwickau Versus Vega Baja, In Healthy Subjects.
Study Start Date :
May 1, 2009
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Jun 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Other: Reference

fesoterodine (Toviaz™ 4 mg) tablet manufactured at Zwickau (Reference)

Drug: Fesoterodine
A fesoterodine extended-release tablet (ER) formulation once daily administration of 4 mg
Other Names:
  • Toviaz 4 mg

    		•
    Other: Test

    fesoterodine (Toviaz™ 4 mg) tablet manufactured at Vega Baja (Test)

    Drug: Fesoterodine
    A fesoterodine extended-release tablet (ER) formulation once daily administration of 4 mg
    Other Names:
  • Toviaz 4 mg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. AUCinf, AUClast, and Cmax of 5-HMT [6 weeks]

    Secondary Outcome Measures

    1. Tmax and half-life of 5-HMT as data permit [6 weeks]

    2. Safety laboratory tests and adverse events [6 weeks]

    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 subjects

    • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

    Exclusion Criteria:

    • Subjects with evidence or history of clinically significant urologic diseases

    • A positive urine drug screen

    • Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Pfizer

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00902187
    Other Study ID Numbers:
    • A0221081
    First Posted:
    May 15, 2009
    Last Update Posted:
    Oct 16, 2018
    Last Verified:
    Oct 1, 2018
    Keywords provided by , ,
    Bioequivalence
    Additional relevant MeSH terms:
    Urinary Bladder, Overactive
    Fesoterodine

    Study Results

    No Results Posted as of Oct 16, 2018