The primary objective of the study was to investigate the relative bioavailability and pharmacokinetics of 20 mg BIBW 2992 administered as film-coated immediate release tablet (final formulation, i.e. phase III/to-be-marketed formulation) to healthy subjects in comparison with the drinking solution and in comparison with the trial formulation II tablet, which was administered in phase II clinical trials and also partly in phase I trials.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
film-coated immediate release tablet - final formulation
film-coated immediate release tablet - trial formulation II
powder for oral solution
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 96 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 96 hours after drug administration
AUC (area under the concentration-time curve of the analyte in plasma) for several time points
Time frame: up to 96 hours after drug administration
%AUCtz-∞ (percentage of the AUCtz-∞ that is obtained by extrapolation from the last quantifiable data point to infinity)
Time frame: up to 96 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 96 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: up to 96 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 96 hours after drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)
Time frame: up to 96 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 96 hours after drug administration
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Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 96 hours after drug administration
Number of patients with adverse events
Time frame: up to 88 days
Assessment of tolerability by the investigator on a 4-point scale
Time frame: Day 5 of each treatment period