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

Completed · Phase 1

Conditions studied: Treatment of Overactive Bladder

In brief

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

Key facts

Study ID

NCT00902681

Run by

Pfizer

People needed

36

Starts

2009-06-01

Expected to finish

2009-08-01

Last updated by the study team

2018-09-28

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male and/or female subjects
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

You may not qualify if…

• 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

Where it is running

• Pfizer Investigational Site — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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