Study to investigate pharmacodynamic effects and pharmacokinetics of KUC 7483
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
26
Change from baseline in "volume at first contraction"
Time frame: 2 hours post dosing
Change from baseline in "volume at first contraction"
Time frame: 6 hours post dosing
Change from baseline in Detrusor pressure at first contraction
Time frame: 2 and 6 hours post dosing
Change from baseline in Maximum amplitude of involuntary detrusor contraction
Time frame: 2 and 6 hours post dosing
Change from baseline in Volume at first incontinence episode
Time frame: 2 and 6 hours post dosing
Change from baseline in compliance
Time frame: 2 and 6 hours post dosing
Change from baseline in Maximum cystometric capacity
Time frame: 2 and 6 hours post dosing
Change from baseline in Detrusor pressure at maximum flow induced by triggering
Time frame: 2 and 6 hours post dosing
Change from baseline in Post-triggering residual urinary volume
Time frame: 2 and 6 hours post dosing
AUC0-∞ (area under the concentration time curve of KUC 7322 ZW in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 24 hours post dosing
Cmax (maximum concentration of KUC 7322 ZW in plasma)
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Time frame: up to 24 hours post dosing
AUC0-tz (area under the concentration-time curve of KUC 7322 ZW in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: up to 24 hours post dosing
AUC0-24 (Area under the concentration time curve of KUC 7322 ZW in plasma over the time interval 0 to 24 hours)
Time frame: up to 24 hours post dosing
tmax (time from dosing to the maximum concentration of KUC 7322 ZW in plasma)
Time frame: up to 24 hours post dosing
λz (terminal rate constant of KUC 7322 ZW in plasma)
Time frame: up to 24 hours post dosing
t1/2 (terminal half-life of KUC 7322 ZW in plasma)
Time frame: up to 24 hours post dosing
MRTpo (mean residence time of KUC 7322 ZW in the body after po administration)
Time frame: up to 24 hours post dosing
CL/F (apparent clearance of KUC 7322 ZW in the plasma after extravascular administration)
Time frame: up to 24 hours post dosing
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 24 hours post dosing
Aet1-t2 (amount of KUC 7322 ZW that is eliminated in urine from the time interval t1 to t2)
Time frame: up to 24 hours post dosing
fet1-t2 (fraction of administered drug excreted unchanged in urine from time point t1 to t2)
Time frame: up to 24 hours post dosing
CLR,t1-t2 (renal clearance of KUC 7322 ZW in plasma from the time point t1 until the time point t2)
Time frame: up to 24 hours post dosing
Number of patients with adverse events
Time frame: up to 26 days
Number of patients with clinically significant changes in vital signs
Blood Pressure
Time frame: up to 24 hours post dosing
Assessment of tolerability by investigator on a 4-point scale
Time frame: 10 days post dosing
Assessment of tolerability by patient on a 4-point scale
Time frame: 10 days post dosing