Safety, tolerability and pharmacokinetics (including comparisons of different formulations and investigation of food effect)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
single rising daily doses
Number of patients with changes in vital signs
blood pressure, pulse rate, respiratory rate, body temperature
Time frame: baseline, up to 8 days after drug administration
Number of patients with changes in electrocardiogram (ECG)
Time frame: baseline, up to 8 days after drug administration
Number of patients with changes in safety laboratory parameters
Time frame: baseline, up to 8 days after drug administration
Number of patients with adverse events
Time frame: baseline, up to 8 days after drug administration
Global tolerability assessment by the investigator on a verbal rating scale
Time frame: up to 8 days after drug administration
Cmax (maximum concentration of the analyte in plasma)
Time frame: up to 32 hours after drug administration
tmax (time from dosing to maximum concentration)
Time frame: up to 32 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)
Time frame: up to 32 hours after drug administration
%AUC0-tz (the percentage of the AUC0-∞ that is obtained by extrapolation)
Time frame: up to 32 hours after drug administration
λz (terminal rate constant in plasma)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 32 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 32 hours after drug administration
MRTpo (mean residence time of the analyte in the body after po administration)
Time frame: up to 32 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 32 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 32 hours after drug administration
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Time frame: up to 32 hours after drug administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Time frame: up to 32 hours after drug administration
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Time frame: up to 32 hours after drug administration