Urinary Bladder, Overactive Clinical Trial
Official title:
An Open-Label, Randomized, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Fesoterodine On The Pharmacokinetics And Pharmacodynamics Of A Single Supratherapeutic Dose Of Warfarin In Healthy Subjects.
Verified date | May 2011 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | August 2009 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Pfizer Investigational Site | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cmax and AUCinf for both S- and R-warfarin | 8 days per period | No | |
Primary | AUC_INR and INRmax | 8 days per period | No | |
Secondary | AUClast, Tmax and t½ for both S- and R-warfarin | 8 days per period | No | |
Secondary | AUC_PT and PTmax | 8 days per period | No | |
Secondary | 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 | No |
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