Study to investigate the effect of the P-gp and cytochrome P450 (CYP) 3A4 inhibitor ritonavir on the pharmacokinetics of BI 1356
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
AUC0-24 (Area under the concentration-time curve of BI 1356 in plasma over the time interval from 0 to 24 hours)
Time frame: up to 24 hours after start of treatment
Cmax (Maximum measured concentration of BI 1356 in plasma)
Time frame: up to 96 hours after start of treatment
AUC (Area under the concentration time curve of the analytes in plasma at different time points)
Time frame: up to 96 hours after start of treatment
%AUCtz-∞ (Percentage of the extrapolated part of the area under the concentration time curve of the analytes in plasma from 0 to infinity)
Time frame: up to 96 hours after start of treatment
tmax (Time from dosing to the maximum concentration of the analytes in plasma)
Time frame: up to 96 hours after start of treatment
t1/2 (Terminal half-life of the analytes in plasma)
Time frame: up to 96 hours after start of treatment
λz (Terminal rate constant of the analytes in plasma)
Time frame: up to 96 hours after start of treatment
MRTpo (Mean residence time in the body after po administration of the analytes in plasma)
Time frame: up to 96 hours after start of treatment
CL/F (Apparent clearance of BI 1356 in plasma after extravascular administration )
Time frame: up to 96 hours after start of treatment
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Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) of BI 1356
Time frame: up to 96 hours after start of treatment
Aet1-t2 (Amount of the analytes that is eliminated in urine from the time interval t1 to t2)
Time frame: up to 24 hours after start of treatment
fet1-t2 (Fraction of BI 1356 excreted unchanged in urine from time point t1 to t2)
Time frame: up to 24 hours after start of treatment
CLR,t1-t2 (Renal clearance of the analytes in plasma)
Time frame: up to 24 hours after start of treatment
Cmax (Maximum measured concentration of CD 1750 in Plasma)
Time frame: up to 96 hours after start of treatment
Number of patients with adverse events
Time frame: up to 53 days