Investigation of the relative bioavailability of 1 mg and 10 mg BI 1356 BS as PIB reconstituted with 0.1% tartaric acid vs. 1 mg and 10 mg BI 1356 BS as tablet including a food effect for the 10 mg tablet dose group
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
Time frame: Up to 264 h after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: Up to 264 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: Up to 264 h 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 264 h after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: Up to 264 h after drug administration
λz (terminal rate constant in plasma)
Time frame: Up to 264 h after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: Up to 264 h after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: Up to 264 h after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: Up to 264 h after drug administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of patients with adverse events
Time frame: Up to 18 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: Up to 18 days after last drug administration
Clinically relevant changes in clinical laboratory values
Time frame: Up to 18 days after last drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)
Time frame: Up to 264 h after drug administration