Study to investigate the pharmacokinetics of BI 1356 after single and multiple oral doses of 5 mg in Chinese healthy subjects
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
single dose
multiple doses
Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state)
Time frame: up to day 19
AUCτ (Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: up to day 19
Cmax (Maximum measured concentration of the analyte in plasma) at different time points after single and multiple doses
Time frame: up to day 19
tmax (Time from dosing to maximum measured concentration) at different time points after single and multiple doses
Time frame: up to day 19
AUC0-infinity (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single dose administration)
Time frame: up to day 7
AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of last quantifiable analyte plasma concentration after single dose administration)
Time frame: up to day 7
AUC0-24 (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours after single dose administration)
Time frame: up to 24 h after single dose administration
AUC0-72 (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours after single dose administration)
Time frame: up to 72 h after single dose administration
λz (Terminal rate constant in plasma) at different time points after single and multiple doses
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Time frame: up to day 19
t1/2 (Terminal half-life of the analyte in plasma) at different time points after single and multiple doses
Time frame: up to day 19
MRTpo (Mean residence time of the analyte in the body) at different time points after single and multiple doses
Time frame: up to day 19
CL/F (Apparent clearance of the analyte in plasma after extravascular administration) at different time points after single and multiple doses
Time frame: up to day 19
Vz/F (Apparent volume of distribution during the terminal phase λz following extravascular administration) at different time points after single and multiple doses
Time frame: up to day 19
Aet1-t2 (Amount of analyte that is eliminated in urine from time point t1 to time point t2) at different time points after single and multiple doses
Time frame: up to 168 h after first dose and up to 24 h after last dose
fet1-t2 (Fraction of analyte eliminated in urine from time point t1 to time point t2) at different time points after single and multiple doses
Time frame: up to 168 h after first dose and up to 24 h after last dose
Cmin,ss (Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) for multiple doses
Time frame: up to 144 h after last dose
Cavg,ss (Average concentration of the analyte in plasma at steady state)
Time frame: up to 144 h after last dose
AUCτ,ss (Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: up to 144 h after last dose
CLRt1-t2,ss (Renal clearance of the analyte at steady state from time point t1 to time point t2)
Time frame: up to 144 h after last dose
Cpre (Predose concentration of the analyte in plasma) at different time points
Time frame: up to 120 h after first of multiple doses
PTF (Peak-Trough Fluctuation)
Time frame: up to 120 h after first of multiple doses
RA,Cmax (Accumulation ratio of the analyte in plasma after multiple dose administration over a uniform dosing interval τ) based on Cmax
Time frame: up to day 19
RA,AUC (Accumulation ratio of the analyte in plasma after multiple dose administration over a uniform dosing interval τ) based on AUCτ
Time frame: up to day 19
Number of patients with adverse events
Time frame: up to 28 days
Number of patients with abnormal findings in physical examination
Time frame: up to 25 days
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 25 days
Number of patients with clinically significant changes in Vital signs (blood pressure [BP], pulse rate [PR])
Time frame: up to 25 days
Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)
Time frame: up to 25 days