The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects
Phase 1
Completed
- Conditions
- Overactive Bladder With Symptoms of Frequency, Urgency, and Urge Urinary Incontinence
- Interventions
- Registration Number
- NCT00911235
- Lead Sponsor
- Pfizer
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description fesoterodine plus fluconazole fesoterodine plus fluconazole Test treatment Fesoterodine Alone Fesoterodine Reference treatment
- Primary Outcome Measures
Name Time Method AUCinf and Cmax of 5-HMT 3 days per period
- Secondary Outcome Measures
Name Time Method AUClast, Tmax and half-life of 5-HMT as data permit. 3 days per period Safety will be assessed by subjective symptoms/objective findings including physical examination findings, clinical safety laboratory assessments and adverse event monitoring. 3 days per period
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸New Haven, Connecticut, United States