To compare the oral bioavailability and rate of absorption of two different formulations of BI 671800 HEA (choline salt) tablets 200 mg, one with enteric coating (EC) and one without EC, versus 2 x 100 mg BI 671800 ED (ethylenediamine salt) capsules. Both BI 671800 HEA formulations were further investigated concerning food effect and one of the two BI 671800 HEA formulations identified by interim pharmacokinetic analysis was further investigated concerning dose proportionality with 50 mg.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Cmax (maximum measured concentration of BI 671800 in plasma)
Time frame: Up to 24 hours after last drug administration
AUC0-∞ (area under the concentration time curve of BI 671800 in plasma over the time interval from 0 extrapolated to infinity)
Time frame: Up to 24 hours after last drug administration
tmax (time from dosing to the maximum concentration of BI 671800 in plasma)
Time frame: Up to 24 hours after last drug administration
AUC0-tz (area under the concentration-time curve of BI 671800 in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: Up to 24 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: Up to 24 hours after drug adminnistration
t½ (terminal half-life of BI 671800 in plasma)
Time frame: Up to 24 hours after drug administration
MRTpo (mean residence time of BI 671800 in the body after po administration)
Time frame: Up to 24 hours after drug administration
CL/F (apparent clearance of BI 671800 in the plasma after extravascular administration)
Time frame: Up to 24 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: Up to 24 hours after drug administration
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Number of patients with clinical significant findings in physical examinations
Time frame: Up to 10 days after last drug admininstration
Number of patients with clinical significant findings in vital signs
Time frame: Up to 10 days after last drug administration
Number of patients with clinical significant findings in ECG
Time frame: Up to 10 days after last drug administration
Number of patients with clinical significant findings in laboratory tests
Time frame: Up to 10 days after last drug administration
Number of patients with adverse events
Time frame: Up to 10 days after last drug administration
Investigator assessed tolerability on a 4 point scale
Time frame: Up to 10 days after last drug administration