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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Treatment of Overactive Bladder

Treatments: Drug: Fesoterodine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00902187

A0221081

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Reference

Other group

Description:

fesoterodine (Toviaz™ 4 mg) tablet manufactured at Zwickau (Reference)

Treatment:

Drug: Fesoterodine

Drug: Fesoterodine

Test

Other group

Description:

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

Treatment:

Drug: Fesoterodine

Drug: Fesoterodine