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

An Open-Label, Randomized, Single-Dose, Two-Way Crossover Bioequivalence Study Of 4 Mg Fesoterodine Extended-Release Tablets (Toviaz™), Manufactured At Zwickau Versus Vega Baja, In Healthy Subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00902187

Enrollment

Registered

2009-05-15

Start date

2009-05-31

Completion date

2009-06-30

Last updated

2018-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of Overactive Bladder

Keywords

Bioequivalence

Brief summary

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

Interventions

DRUGFesoterodine

A fesoterodine extended-release tablet (ER) formulation once daily administration of 4 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
AUCinf, AUClast, and Cmax of 5-HMT	6 weeks

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026