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

Treatment of Overactive Bladder Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902681
• Other study ID #: A0221082
• Status: Completed
• Phase: Phase 1
• Start date: June 2009
• Est. completion date: August 2009

Study information

• Verified date: September 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Treatment of Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCinf, AUClast, and Cmax of 5-HMT		6 weeks
Secondary	Tmax and half-life of 5-HMT as data permit.		6 weeks
Secondary	Safety laboratory tests and adverse events		6 weeks

External Links

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