To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 44847
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Number of patients with adverse events
Time frame: up to day 12
Number of patients with clinically significant findings in vital signs (blood pressure, pulse rate)
Time frame: up to day 12
Number of patients with clinically significant findings in ECG
Time frame: up to day 12
Number of patients with clinically significant laboratory findings
Time frame: up to day 12
Assessment of tolerability by the investigator on a 4-point scale
Time frame: up to day 12
Cmax (maximum concentration of the analyte in plasma)
Time frame: up to 96 hours after drug administration
tmax (time from dosing to maximum concentration)
Time frame: up to 96 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 96 hours after drug administration
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
Time frame: up to 96 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 time of the last quantifiable data point)
Time frame: up to 96 hours after drug administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
λz (terminal rate constant in plasma)
Time frame: up to 96 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 96 hours after drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)
Time frame: up to 96 hours after drug administration
CL/F (total clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 96 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 96 hours after drug administration
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
Time frame: up to 72 hours after drug administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Time frame: up to 72 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 72 hours after drug administration
Area under the plasma glucose concentration time curve
Time frame: up to 96 hours after drug administration
Total amount of glucose excreted in urine
Time frame: up to 72 hours after drug administration
Maximum glucose concentration in plasma
Time frame: up to 96 hours after drug administration
Maximum glucose concentration in urine
Time frame: up to 72 hours after drug administration