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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00902681
First received: May 14, 2009
Last updated: May 31, 2011
Last verified: May 2011
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tmax and half-life of 5-HMT as data permit. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Safety laboratory tests and adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00902681     History of Changes
Other Study ID Numbers: A0221082
Study First Received: May 14, 2009
Last Updated: May 31, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Bioequivalence, Pharmacokinetics

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014