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



Status:Completed
Conditions:Overactive Bladder
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 55
Updated:9/30/2018
Start Date:June 2009
End Date:August 2009

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Trial Summary
Trial Overview
Inclusion Criteria

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.

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


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