A Double-blind, Randomised, Placebo Controlled (Within a Dose Group) Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Rising Inhalative Doses (5 μg, 10 μg and 20 μg) of BI 1744 CL for 14 Days in Healthy Male Volunteers

BI 1744 CL

Placebo

Number of patients with abnormal findings in physical examination

Number of patients with clinically relevant findings in vital signs (blood pressure, pulse rate)

Number of patients with abnormal findings in 12-lead electrocardiogram (ECG)

Number of patients with clinically significant changes in clinical laboratory tests

Change from baseline in potassium level

Number of patients with adverse events

Assessment of tolerability on a 4-point scale

Cmax (maximum measured concentration of the analyte in plasma at different time points)

tmax (time from dosing to maximum measured concentration of the analyte in plasma at different time points)

AUC (area under the concentration-time curve of the analyte in plasma at different time points)

%AUCtz-∞ (the percentage of the AUC 0-infinity that is obtained by extrapolation)

λz (terminal rate constant in plasma at different time points)

t1/2 (terminal half-life of the analyte in plasma at different time points)

MRTih (mean residence time of the analyte in the body after inhalation administration at different time points)

Aeτ (amount of analyte that is eliminated in urine after administration over a uniform dosing interval τ at different time points)

feτ (fraction of analyte eliminated in urine after administration over a uniform dosing interval τ at different time points)

CLR (renal clearance of the analyte at different time points)

Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)

Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)

AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)

CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration)

Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)

Accumulation ratio (RA,AUC)

Accumulation ratio (RA,Cmax)