To compare the oral bioavailability and rate of absorption of four prototype extended-release (ER) formulations with BI 11634 (single doses) to immediate-release (IR) tablets in healthy male volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
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 48 hours after drug administraton
Cmax (maximum measured concentration of analyte in plasma)
Time frame: up to 48 hours after drug administraton
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 48 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 48 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: up to 48 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 48 hours after drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)
Time frame: up to 48 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 48 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 48 hours after drug administration
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Fluctuation parameter Cmax/C24 ratio
Time frame: up to 48 hours after drug administration
Maximum prolongation of blood coagulation time
by HepTest® (Haemachem Inc.)
Time frame: up to 48 hours after drug administration
Number of subjects with adverse events
Time frame: up to 8 days after last drug administration
Number of subjects with clinically significant findings in vital signs (blood pressure, pulse rate)
Time frame: up to 8 days after last drug administration
Number of subjects with clinically significant findings in ECG
Time frame: up to 8 days after last drug administration
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 8 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: up to 8 days after last drug administration
% Inhibition of Factor Xa
by Russel's Viper Venom test (RVV)
Time frame: up to 48 hours after drug administration