To investigate the relative bioavailability of BI 14332 CL vs. BI 14332 CL after intake of a standardised high fat breakfast
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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 192 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 192 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 192 hours after drug administration
AUCt1-t2 (partial area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2)
Time frame: up to 192 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 192 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: up to 192 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 192 hours after drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)
Time frame: up to 192 hours after drug administration
CL/F (apparent clearance of the analyte in plasma after extravascular administration)
Time frame: up to 192 hours after drug administration
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Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 192 hours after drug administration
Number of patients with adverse events
Time frame: up to 23 days after last drug administration
Number of patients with clinically significant findings in vital signs (blood pressure, pulse rate)
Time frame: up to 23 days after last drug administration
Number of patients with clinically significant findings in laboratory tests
Time frame: up to 23 days after last drug administration
Number of patients with clinically significant findings in ECG
Time frame: up to 23 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: up to 23 days after last drug administration