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

Pfizer36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Treatment of Overactive Bladder

Interventions

FesoterodineDRUG

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

FesoterodineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

AUCinf, AUClast, and Cmax of 5-HMT

Time frame: 6 weeks

Secondary Outcomes

Tmax and half-life of 5-HMT as data permit.

Time frame: 6 weeks

Safety laboratory tests and adverse events

Time frame: 6 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.