Status:
COMPLETED
A Bioequivalence Study Of 4 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects
Lead Sponsor:
Pfizer
Conditions:
Treatment of Overactive Bladder
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
To demonstrate bioequivalence of fesoterodine 4 mg tablets manufactured at Vega Baja, versus Zwickau.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00902187
Start Date
May 1 2009
End Date
June 1 2009
Last Update
October 16 2018
Active Locations (1)
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1
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511