The Effect Of Fesoterodine On Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects
Phase 1
Completed
- Conditions
- Urinary Bladder, Overactive
- Interventions
- Registration Number
- NCT00914667
- Lead Sponsor
- Pfizer
- Brief Summary
This is an open-label, randomized, two-way crossover study to evaluate the steady-state effect of fesoterodine (8 mg QD) on the pharmacodynamics and pharmacokinetics of a single supratherapeutic dose of warfarin (25 mg) in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Healthy male and/or female subjects between the ages of 18 and 55 years
Exclusion Criteria
- Not healthy subjects--subjects with acute or chronic medical or psychiatric conditions or laboratory abnormality
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Warfarin Concomitantly With Fesoterodine Warfarin plus Fesoterodine Test treatment Warfarin Alone warfarin Reference treatment
- Primary Outcome Measures
Name Time Method Cmax and AUCinf for both S- and R-warfarin 8 days per period AUC_INR and INRmax 8 days per period
- Secondary Outcome Measures
Name Time Method AUClast, Tmax and t½ for both S- and R-warfarin 8 days per period AUC_PT and PTmax 8 days per period Safety will be assessed by subjective symptoms/objective findings including physical examinations, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements and adverse event monitoring. 8 days per period
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸New Haven, Connecticut, United States
Pfizer Investigational Site🇺🇸New Haven, Connecticut, United States