The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00911235

Purpose

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
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:

MedlinePlus related topics: Urinary Incontinence

Drug Information available for: Fluconazole Fesoterodine Fesoterodine fumarate

U.S. FDA Resources

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 ]

Estimated Enrollment:	28
Study Start Date:	May 2009
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Fesoterodine Alone: Experimental 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)

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911235

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0221080
Study First Received:	May 28, 2009
Last Updated:	August 17, 2009
ClinicalTrials.gov Identifier:	NCT00911235 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects

Study placed in the following topic categories:

Fluconazole
Anti-Infective Agents
Signs and Symptoms
Urinary Bladder, Overactive
Cystocele
Urologic Diseases

Urination Disorders
Antifungal Agents
Urinary Bladder Diseases
Urinary Incontinence
Healthy
Urinary Incontinence, Urge

Additional relevant MeSH terms:

Fluconazole
Urinary Bladder, Overactive
Anti-Infective Agents
Urination Disorders
Urinary Bladder Diseases
Pharmacologic Actions
Urological Manifestations

Signs and Symptoms
Urologic Diseases
Antifungal Agents
Therapeutic Uses
Urinary Incontinence
Urinary Incontinence, Urge

ClinicalTrials.gov processed this record on September 11, 2009