Overactive Bladder With Symptoms of Frequency, Urgency, and Urge Urinary Incontinence
Conditions
Keywords
The Effect Of Fluconazole On 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.
Interventions
DRUGFesoterodine
Single 8 mg oral dose of fesoterodine
DRUGfesoterodine 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)
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCinf and Cmax of 5-HMT | 3 days per period |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed