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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00902681
First Posted: May 15, 2009
Last Update Posted: June 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
This bioequivalence (BE) study is to satisfy FDA regulatory requirements for extended releases drug product transfer from Zwickau, Germany to Vega Baja, Puerto-Rico.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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.

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 ]

Estimated Enrollment: 36
Study Start Date: June 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Reference
a single dose of 8 mg fesoterodine (Toviaz™ 8 mg) tablet manufactured at Zwickau
Drug: Fesoterodine
A fesoterodine extended-release tablet (ER) formulation once daily administration of 8 mg
Other Name: Toviaz 8 mg
Test
a single dose of 8 mg fesoterodine (Toviaz™ 8 mg) tablet manufactured at Vega Baja (Test)
Drug: Fesoterodine
A fesoterodine extended-release tablet (ER) formulation once daily administration of 8 mg
Other Name: Toviaz 8 mg

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902681


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

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00902681     History of Changes
Other Study ID Numbers: A0221082
First Submitted: May 14, 2009
First Posted: May 15, 2009
Last Update Posted: June 1, 2011
Last Verified: May 2011

Keywords provided by Pfizer:
Bioequivalence, Pharmacokinetics

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Fesoterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents