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

Phase 1

Completed

• Conditions: Treatment of Overactive Bladder
• Interventions: Drug: Fesoterodine

• Registration Number: NCT00902681
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-14
• Study First Submitted QC: 2009-05-14
• Study First Posted: 2009-05-15
• Study Start: 2009-06
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-26
• Last Update Posted: 2018-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test	Fesoterodine	a single dose of 8 mg fesoterodine (Toviaz™ 8 mg) tablet manufactured at Vega Baja (Test)
Reference	Fesoterodine	a single dose of 8 mg fesoterodine (Toviaz™ 8 mg) tablet manufactured at Zwickau

Primary Outcome Measures

Name	Time	Method
AUCinf, AUClast, and Cmax of 5-HMT	6 weeks

Secondary Outcome Measures

Name	Time	Method
Tmax and half-life of 5-HMT as data permit.	6 weeks
Safety laboratory tests and adverse events	6 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States