To investigate the food effect on the relative bioavailability and pharmacokinetics of a 5 mg BI 1356 tablet administered as a single dose
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Area under the concentration-time curve of BI 1356 in plasma over the time interval from 0 to 72 h (AUC0-72)
Time frame: up to 72 hours after start of treatment
Maximum measured concentration (Cmax) of BI 1356 in plasma
Time frame: up to 96 hours after start of treatment
Area under the concentration-time curve of BI 1356 in plasma at different time points
Time frame: up to 96 hours after start of treatment
Time from dosing to the maximum concentration (tmax) of BI 1356 in plasma
Time frame: up to 96 hours after start of treatment
Terminal elimination rate constant (λz) in plasma
Time frame: up to 96 hours after start of treatment
Terminal half-life (t1/2) of BI 1356 in plasma
Time frame: up to 96 hours after start of treatment
Mean residence time of BI 1356 in the body after oral administration (MRTpo)
Time frame: up to 96 hours after start of treatment
Apparent clearance of BI 1356 in the plasma after extravascular administration (CL/F)
Time frame: up to 96 hours after start of treatment
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Time frame: up to 96 hours after start of treatment
Number of patients with adverse events
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Time frame: up to 11 weeks
Assessment of tolerability on a 4-point scale by investigator
Time frame: 14 days after last study drug administration