A Bioequivalence Study Of 8 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

NCT00902681

A0221082

Details and patient eligibility

About

This bioequivalence (BE) study is to satisfy FDA regulatory requirements for extended releases drug product transfer from Zwickau, Germany to Vega Baja, Puerto-Rico.

Enrollment: 36 estimated 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

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:

a single dose of 8 mg fesoterodine (Toviaz™ 8 mg) tablet manufactured at Zwickau

Treatment:

Drug: Fesoterodine

Drug: Fesoterodine

Test

Other group

Description:

a single dose of 8 mg fesoterodine (Toviaz™ 8 mg) tablet manufactured at Vega Baja (Test)

Treatment:

Drug: Fesoterodine

Drug: Fesoterodine