The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects
NCT00911235
Last updated date
ABOUT THIS STUDY
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Urgency Overactive Bladder With Symptoms of Frequency
Sex
Females and Males
Age
18-55 years
Inclusion Criteria
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- Healthy subjects between the ages of 18 and 55 years
Exclusion Criteria
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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
- New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
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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 |
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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 |