The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects

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NCT00911235

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
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1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Urgency Overactive Bladder With Symptoms of Frequency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy subjects between the ages of 18 and 55 years

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Not healthy subjects. subjects with acute or chronic medical or psychiatric condition
or laboratory abnormality

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Urgency Overactive Bladder With Symptoms of FrequencyThe Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects
NCT00911235
  1. New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Overactive Bladder With Symptoms of Frequency, Urgency, and Urge Urinary Incontinence
Intervention  ICMJE
  • Drug: Fesoterodine
    Single 8 mg oral dose of fesoterodine
  • 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)
Study Arms  ICMJE
  • Experimental: Fesoterodine Alone
    Reference treatment
    Intervention: Drug: Fesoterodine
  • fesoterodine plus fluconazole
    Test treatment
    Intervention: Drug: fesoterodine plus fluconazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 28, 2009)		28
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00911235
Other Study ID Numbers  ICMJE A0221080
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP