The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00911235
First received: May 28, 2009
Last updated: May 31, 2011
Last verified: May 2011
  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 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)

  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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov 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 Incontinence
Urinary Incontinence, Urge
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Fluconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014