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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Fesoterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014