A Bioequivalence Study Of 4 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects
Overview
To demonstrate bioequivalence of fesoterodine 4 mg tablets manufactured at Vega Baja, versus Zwickau.
Full Title of Study: “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.”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Other
- Masking: None (Open Label)
- Study Primary Completion Date: June 2009
Interventions
- Drug: Fesoterodine
- A fesoterodine extended-release tablet (ER) formulation once daily administration of 4 mg
- Drug: Fesoterodine
- A fesoterodine extended-release tablet (ER) formulation once daily administration of 4 mg
Arms, Groups and Cohorts
- Other: Reference
- fesoterodine (Toviaz™ 4 mg) tablet manufactured at Zwickau (Reference)
- Other: Test
- fesoterodine (Toviaz™ 4 mg) tablet manufactured at Vega Baja (Test)
Clinical Trial Outcome Measures
Primary Measures
- AUCinf, AUClast, and Cmax of 5-HMT
- Time Frame: 6 weeks
Secondary Measures
- Tmax and half-life of 5-HMT as data permit
- Time Frame: 6 weeks
- Safety laboratory tests and adverse events
- Time Frame: 6 weeks
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 55 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Pfizer
- Provider of Information About this Clinical Study
- Director, Clinical Trial Disclosure Group, Pfizer, Inc.
- Overall Official(s)
- Pfizer CT.gov Call Center, Study Director, Pfizer
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