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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Fesoterodine

Criteria

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