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



Status:Completed
Conditions:Overactive Bladder
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 55
Updated:10/18/2018
Start Date:May 2009
End Date:June 2009

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Trial Summary
Trial Overview
Inclusion Criteria

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.

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


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
We found this trial at
1
site
Pfizer Investigational Site
New Haven, Connecticut 06504
?
mi
from
New Haven, CT
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