Study to assess pharmacokinetics incl. dose proportionality, safety and tolerability of 4 different dosage strengths of BIBW 2992 tablets (final formulation of 20 mg, 30 mg, 40 mg, 50 mg) administered as single doses to healthy male volunteers
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: predose, up to120 h 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: predose, up to 120 h 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: predose, up to 120 h after drug administration
%AUCtz-∞ (percentage of the AUCtz-∞ obtained by extrapolation from the last quantifiable data point to infinity)
Time frame: predose, up to 120 h after drug administration
AUC0-24 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 [predose] to 24 h)
Time frame: predose, up to 120 h after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: predose, up to 120 h after drug administration
λz (terminal rate constant of the analyte in plasma)
Time frame: predose, up to 120 h after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: predose, up to 120 h days after drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)
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Time frame: predose, up to 120 h after drug administration
CL/F (apparent clearance of the analyte in plasma after extravascular administration)
Time frame: predose, up to 120 h after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: predose, up to 120 h after drug administration
Number of patients with abnormal findings in physical examination
Time frame: Screening, up to 20 days after drug administration
Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)
Time frame: Screening, up to 20 days after drug administration
Number of patients with abnormal changes in laboratory parameters
Time frame: Screening, up to 20 days after drug administration
Number of patients with adverse events
Time frame: up to 41 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: up to 20 days after drug administration
Number of patients with abnormal changes in 12-lead electrocardiogram (ECG)
Time frame: Screening, up to 20 days after drug administration