Status:
COMPLETED
A Bioequivalence Study Of 8 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
This bioequivalence (BE) study is to satisfy FDA regulatory requirements for extended releases drug product transfer from Zwickau, Germany to Vega Baja, Puerto-Rico.
Eligibility Criteria
Inclusion
- Healthy male and/or female subjects
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
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 :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00902681
Start Date
June 1 2009
End Date
August 1 2009
Last Update
September 28 2018
Active Locations (1)
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1
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511