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A Bioequivalence Study Of 8 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00902681
Collaborator
(none)
36
Enrollment
1
Location
2
Arms
2
Duration (Months)
18
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This bioequivalence (BE) study is to satisfy FDA regulatory requirements for extended releases drug product transfer from Zwickau, Germany to Vega Baja, Puerto-Rico.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 8 Mg Fesoterodine Extended-Release Tablets (Toviaz™), Manufactured At Zwickau Versus Vega Baja, In Healthy Subjects.
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Aug 1, 2009
Actual Study Completion Date :
Aug 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Other: Reference

a single dose of 8 mg fesoterodine (Toviaz™ 8 mg) tablet manufactured at Zwickau

Drug: Fesoterodine
A fesoterodine extended-release tablet (ER) formulation once daily administration of 8 mg
Other Names:
  • Toviaz 8 mg

    		•
    Other: Test

    a single dose of 8 mg fesoterodine (Toviaz™ 8 mg) tablet manufactured at Vega Baja (Test)

    Drug: Fesoterodine
    A fesoterodine extended-release tablet (ER) formulation once daily administration of 8 mg
    Other Names:
  • Toviaz 8 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

    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:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT00902681
    Other Study ID Numbers:
    • A0221082
    First Posted:
    May 15, 2009
    Last Update Posted:
    Sep 28, 2018
    Last Verified:
    Sep 1, 2018
    Keywords provided by Pfizer
    Bioequivalence, Pharmacokinetics
    Additional relevant MeSH terms:
    Urinary Bladder, Overactive
    Fesoterodine

    Study Results

    No Results Posted as of Sep 28, 2018