To investigate safety, tolerability, and pharmacokinetics of BI 1744 CL
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
122
Number of patients with abnormal findings in physical examination
Time frame: 12 days after drug administration
Number of patients with clinically significant changes in vital signs
Time frame: Baseline, up to 12 days after drug administration
Change in orthostasis test parameters
Time frame: Baseline, up to 24 hours after drug administration
Number of patients with abnormal changes in laboratory parameters
Time frame: Baseline, up to 12 days after drug administration
Change in oral body temperature
Time frame: Baseline, up to 24 hours after drug administration
Number of patients with abnormal changes in 12-lead ECG (electrocardiogram) parameters
Time frame: Baseline, up to 12 days after drug administration
Number of patients with adverse events
Time frame: Up to 12 days
Change in tremormetry parameters
Time frame: Baseline, up to 24 hours after drug administration
Number of patients with abnormal findings of oropharyngeal inspection
Time frame: Baseline, up to 24 hours after drug administration
Number of patients with abnormal findings of pulmonary auscultation
Time frame: Baseline, up to 24 hours after drug administration
Change in airway resistance (Raw), as measured by body plethysmography
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Time frame: Baseline, up to 24 hours after drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: 12 days after drug administration
Area under the concentration-time curve of BI 1744 CL in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)
Time frame: Up to 96 hours after drug administration
Area under the concentration-time curve of BI 1744 CL in plasma over the time interval from 0 to 24 hours (AUC0-24)
Time frame: Up to 96 hours after drug administration
Maximum concentration of BI 1744 CL in plasma (Cmax)
Time frame: Up to 96 hours after drug administration
Time from dosing to maximum concentration (tmax)
Time frame: Up to 96 hours after drug administration
Amount of BI 1744 CLeliminated in urine from the time point t1 to time point t2 (Aet1-t2)
Time frame: Up to 96 hours after drug administration
Fraction of BI 1744 CL eliminated in urine from time point t1 to time point t2 (fet1-t2)
Time frame: Up to 96 hours after drug administration
Renal clearance of BI 1744 CL from 0 to 24 hours (CLR,0-24)
Time frame: Up to 24 hours after drug administration
Terminal rate constant of BI 1744 CL in plasma (λz)
Time frame: Up to 96 hours after drug administration
Terminal half-life of BI 1744 CL in plasma (t½)
Time frame: Up to 96 hours after drug administration
Area under the concentration-time curve of BI 1744 CL in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: Up to 96 hours after drug administration
AUC0-tz over AUC0-∞ (%AUC0-tz)
Time frame: Up to 96 hours after drug administration
Mean residence time of BI 1744 CL in the body after inhalation (MRTih)
Time frame: Up to 96 hours after drug administration
Apparent clearance of BI 1744 CL in the plasma after extravascular administration (CL/F)
Time frame: Up to 96 hours after drug administration
Apparent volume of distribution of BI 1744 CL during the terminal phase λz following an extravascular dose (Vz/F)
Time frame: Up to 96 hours after drug administration