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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