Evaluation of safety, tolerability and pharmacokinetics of multiple rising oral doses of BI 44370 TA in healthy male and female volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
34
Number of patients with adverse events
Time frame: up to 36 days
Number of patients with clinically relevant findings in vital signs
Time frame: up to 7 days after last drug administration
Number of patients with clinically relevant findings in 12-lead ECG (electrocardiogram)
Time frame: up to 7 days after last drug administration
Number of patients with clinically relevant laboratory findings
Time frame: up to 7 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: up to 7 days after last drug administration
Maximum measured concentration of the analyte in plasma (Cmax ) for several time points
Time frame: up to 4 days
Time from dosing to maximum measured concentration of the analyte in plasma (tmax) for several time points
Time frame: up to 4 days
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC) for several time points
Time frame: up to 4 days
The percentage of the AUC 0-∞ that is obtained by extrapolation (%AUCtz-∞) for several time points
Time frame: up to 4 days
Terminal rate constant in plasma (λz) for several time points
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Time frame: up to 4 days
Terminal half-life of the analyte in plasma (t1/2) for several time points
Time frame: up to 4 days
Mean residence time of the analyte in the body after p.o. administration (MRTpo) for several time points
Time frame: up to 4 days
Apparent clearance of the analyte in plasma following extravascular administration (CL/F) for several time points
Time frame: up to 4 days
Apparent volume of distribution during the terminal phase λz following an extravascular administration (Vz/F) for several time points
Time frame: up to 4 days
Amount of analyte that is eliminated in urine from zero to 24 h after drug administration (Ae0-24) for several time points
Time frame: up to 4 days
Fraction of analyte eliminated in urine from zero to 24 h after drug administration (fe0-24) for several time points
Time frame: up to 4 days
Renal clearance of the analyte from zero to 24 h after drug administration (CLR,0-24) for several time points
Time frame: up to 4 days
Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Time frame: up to 4 days
Accumulation ratio (RA) based on Cmax for several time points
Time frame: up to 4 days
RA based on AUC for several time points
Time frame: up to 4 days
Linearity index (LI) of the analyte in plasma
Time frame: up to 4 days