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The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects

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NCT00911235

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
See other locations
Contact
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.
Show details

- 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.
Show details

- Not healthy subjects. subjects with acute or chronic medical or psychiatric condition
or laboratory abnormality

NCT00911235
Pfizer
Completed
The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects

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The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects
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.
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Overactive Bladder With Symptoms of Frequency, Urgency, and Urge Urinary Incontinence
  • 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)
  • Experimental: Fesoterodine Alone
    Reference treatment
    Intervention: Drug: Fesoterodine
  • fesoterodine plus fluconazole
    Test treatment
    Intervention: Drug: fesoterodine plus fluconazole
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
July 2009
July 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00911235
A0221080
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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