Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Number of subjects with abnormal findings in physical examination
Time frame: up to 8 days after last drug administration
Number of subjects with abnormal changes in laboratory parameters
special parameters, Tropanin I, insulin, C-Peptide, glucagon, free fatty acids, lactate, potassium, cAMP and faecal occult blood testing
Time frame: up to 8 days after last drug administration
Number of subjects with clinically significant changes in vital signs
Blood Pressure, Pulse Rate, Respiratory Rate, body temperature, orthostatic testing
Time frame: up to 8 days after last drug administration
Number of subjects with clinically significant changes in 12-lead ECG (electrocardiogram)
Time frame: up to 8 days after last drug administration
Number of subjects with adverse events
Time frame: up to 8 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: 8 days after last drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 48 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 48 hours after drug administration
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 48 hours after drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Time frame: up to 48 hours after drug administration
λ z (terminal rate constant of the analyte in plasma)
Time frame: up to 48 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 48 hours after drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)
Time frame: up to 48 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 48 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 48 hours after drug administration
Aet1-t2 (amount of the analyte that is eliminated in urine from the time point t1 until time point t2)
Time frame: up to 48 hours after drug administration
fet1-t2 (fraction of administered drug excreted unchanged in urine from the time point t1 until time point t2)
Time frame: up to 48 hours after drug administration
CLR,t1-t2 (renal clearance of the analyte determined from the time point t1 until time point t2)
Time frame: up to 48 hours after drug administration