The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: May 28, 2009
Last updated: May 31, 2011
Last verified: May 2011
This study is designed to estimate the effect of fluconazole (200 mg BID for 2 days), a moderate CYP3A4 inhibitor on the pharmacokinetics of a single 8 mg oral dose of fesoterodine in healthy adult subjects.

Condition Intervention Phase
Overactive Bladder With Symptoms of Frequency, Urgency, and Urge Urinary Incontinence
Drug: Fesoterodine
Drug: fesoterodine plus fluconazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Two-Way Crossover Study To Evaluate The Effect Of Fluconazole, A Moderate CYP3A4 Inhibitor, On The Single-Dose Pharmacokinetics Of Fesoterodine In Healthy Subjects.

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • AUCinf and Cmax of 5-HMT [ Time Frame: 3 days per period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUClast, Tmax and half-life of 5-HMT as data permit. [ Time Frame: 3 days per period ] [ Designated as safety issue: No ]
  • Safety will be assessed by subjective symptoms/objective findings including physical examination findings, clinical safety laboratory assessments and adverse event monitoring. [ Time Frame: 3 days per period ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: May 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fesoterodine Alone
Reference treatment
Drug: Fesoterodine
Single 8 mg oral dose of fesoterodine
fesoterodine plus fluconazole
Test treatment
Drug: fesoterodine plus fluconazole
On Day 1, fluconazole (200 mg oral dose) will be given 1 hour before and approximately 11 hour following a single 8 mg oral dose of fesoterodine (fesoterodine SD). Fluconazole will also be administered 200 mg BID on the Day 2 (ie, at approximately 24 and 36 hours following the fesoterodine SD treatment given on Day 1)


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy subjects between the ages of 18 and 55 years

Exclusion Criteria:

  • Not healthy subjects. subjects with acute or chronic medical or psychiatric condition or laboratory abnormality
  Contacts and Locations
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Please refer to this study by its identifier: NCT00911235

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00911235     History of Changes
Other Study ID Numbers: A0221080 
Study First Received: May 28, 2009
Last Updated: May 31, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Incontinence
Urinary Incontinence, Urge
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Cholinergic Agents
Cholinergic Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents processed this record on February 09, 2016