A Bioequivalence Study Of 4 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects

Phase 1

Completed

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

• Registration Number: NCT00902187
• Lead Sponsor: Pfizer

Brief Summary

To demonstrate bioequivalence of fesoterodine 4 mg tablets manufactured at Vega Baja, versus Zwickau.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-14
• Study First Submitted QC: 2009-05-14
• Study First Posted: 2009-05-15
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-11
• Last Update Posted: 2018-10-16

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; and a total body weight >50 kg (110 lbs).

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	fesoterodine (Toviaz™ 4 mg) tablet manufactured at Vega Baja (Test)
Reference	Fesoterodine	fesoterodine (Toviaz™ 4 mg) tablet manufactured at Zwickau (Reference)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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