The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects

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. Identifier: NCT00911235
Recruitment Status : Completed
First Posted : June 1, 2009
Last Update Posted : June 1, 2011
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Brief Summary:
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 or disease Intervention/treatment Phase
Overactive Bladder With Symptoms of Frequency, Urgency, and Urge Urinary Incontinence Drug: Fesoterodine Drug: fesoterodine plus fluconazole Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Study Start Date : May 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. AUCinf and Cmax of 5-HMT [ Time Frame: 3 days per period ]

Secondary Outcome Measures :
  1. AUClast, Tmax and half-life of 5-HMT as data permit. [ Time Frame: 3 days per period ]
  2. 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 ]

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

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 identifier (NCT number): NCT00911235

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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00911235     History of Changes
Other Study ID Numbers: A0221080
First Posted: June 1, 2009    Key Record Dates
Last Update Posted: June 1, 2011
Last Verified: May 2011

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

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Bladder, Overactive
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents