The purpose of this study is to evaluate pharmacological effect, safety and pharmacokinetic of TAS-303 in female patients with Stress Urinary Incontinence.
This study is double-blind, placebo-controlled crossover study. The main purpose of this study is to evaluate Urethral Pressure Profile Parameters in Stress Urinary Incontinence patients who will receive single dose of TAS-303 or Placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
16
Taiho Pharmaceutical Co., Ltd selected site
Kumamoto, Japan
Change from baseline in Maximum Urethral Closure Pressure (MUCP)
Time frame: Baseline, 6 hours after the administration
Urethral pressure profile parameters: mean urethral closure pressure, functional profile length
Time frame: Baseline, 6 hours after the administration
Safety assessed by incidence and severity of adverse events
Time frame: Up to 36 days after the administration
Maximum plasma concentration (Cmax) of TAS-303
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration
Time to maximum plasma concentration (tmax) of TAS-303
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration
Area under the plasma concentration versus time curve (AUC) of TAS-303
Time frame: Immediately prior to dosing, and 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration
Elimination half-time (t1/2) of TAS-303
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration
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