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

An Open-Label, Randomized, Single-Dose, Two-Way Crossover Bioequivalence Study Of 8 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

NCT00902681

Enrollment

Registered

2009-05-15

Start date

2009-06-30

Completion date

2009-08-31

Last updated

2018-09-28

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, Pharmacokinetics

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.

Interventions

DRUGFesoterodine

A fesoterodine extended-release tablet (ER) formulation once daily administration of 8 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

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