The objective of this trial was to evaluate the relative oral bioavailability and pharmacokinetics of BI 44370 TA drinking solution (100 mg and 200 mg) and BI 44370 TA tablets (100 mg as two 50 mg tablets) with and without a high fat meal and to assess the safety and tolerability of the substances.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Cmax (maximum concentration of the analyte in plasma)
Time frame: up to 24 hours after drug administration
AUC0-2 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 2 h after drug administration)
Time frame: up to 2 hours 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: up to 24 hours after drug administration
tmax (time from dosing to maximum measured concentration)
Time frame: up to 24 hours after drug administration
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
Time frame: up to 24 hours 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 24 hours after drug administration
AUCt1-t2 (Area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2)
Time frame: up to 24 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: up to 24 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 24 hours after drug administration
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MRTp.o. (mean residence time of the analyte in the body after p.o. administration)
Time frame: up to 24 hours after drug administration
CL/F (total/apparent clearance of the analyte in 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
Number of patients with clinically relevant findings in vital signs (blood pressure and pulse rate)
Time frame: up to 11 days
Number of patients with clinically relevant findings in 12-lead ECG (electrocardiogram)
Time frame: up to 11 days
Number of patients with clinically relevant laboratory findings
Time frame: up to 11 days
Number of patients with adverse events
Time frame: up to 34 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: within 10 days after administration of study drug