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A Bioequivalence Study Of 4 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: May 14, 2009
Last updated: June 24, 2010
Last verified: June 2010
To demonstrate bioequivalence of fesoterodine 4 mg tablets manufactured at Vega Baja, versus Zwickau.

Condition Intervention Phase
Treatment of Overactive Bladder
Drug: Fesoterodine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • AUCinf, AUClast, and Cmax of 5-HMT [ Time Frame: 6 weeks ]

Secondary Outcome 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 ]

Enrollment: 36
Study Start Date: May 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
fesoterodine (Toviaz™ 4 mg) tablet manufactured at Zwickau (Reference)
Drug: Fesoterodine
A fesoterodine extended-release tablet (ER) formulation once daily administration of 4 mg
Other Name: Toviaz 4 mg
fesoterodine (Toviaz™ 4 mg) tablet manufactured at Vega Baja (Test)
Drug: Fesoterodine
A fesoterodine extended-release tablet (ER) formulation once daily administration of 4 mg
Other Name: Toviaz 4 mg


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00902187

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00902187     History of Changes
Other Study ID Numbers: A0221081
Study First Received: May 14, 2009
Last Updated: June 24, 2010

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents processed this record on May 25, 2017