To investigate whether and to what extent BI 1356 affects pharmacokinetic and pharmacodynamic parameters of warfarin
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: Up to 168 hours after start of study medication
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: Up to 168 hours after start of study medication
Area under the concentration time curve (AUC) of the analyte in plasma at different time points
Time frame: Up to 168 hours after start of study medication
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time frame: Up to 168 hours after start of study medication
Terminal rate constant in plasma (λz)
Time frame: Up to 168 hours after start of study medication
Terminal half life of the analyte in plasma (t1/2)
Time frame: Up to 168 hours after start of study medication
Mean residence time of the analyte in the body after p.o. administration (MRTpo)
Time frame: Up to 168 hours after start of study medication
Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
Time frame: Up to 168 hours after start of study medication
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Time frame: Up to 168 hours after start of study medication
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Number of patients with adverse events
Time frame: Up 42 days
Number of patients with relevant changes in physical examination
Time frame: Up to 14 days after last study drug administration
Number of patients with relevant changes in vital signs (Blood Pressure (BP), Pulse Rate (PR))
Time frame: Up to 14 days after last study drug administration
Number of patients with relevant changes in 12-lead resting electrocardiogram (ECG)
Time frame: Up to 14 days after last study drug administration
Number of patients with relevant changes in laboratory values
Time frame: Up to 14 days after last study drug administration
Assessment of tolerability a 4-point scale by the investigator
Time frame: Up 42 days
International normalised ratio, area under the concentration time curve of the analyte in plasma over the time interval from time zero to 168 hours (INR AUC0-168)
Time frame: Up to 168 hours after start of treatment
International normalised ratio, maximum concentration of the analyte in plasma (INRmax)
Time frame: Up to 168 hours after start of treatment
Prothrombin time, area under the concentration time curve of the analyte in plasma over the time interval from time zero to 168 hours (PT AUC0-168)
Time frame: Up to 168 hours after start of treatment
Prothrombin time, maximum concentration of the analyte in plasma (PTmax)
Time frame: Up to 168 hours after start of treatment