Study to evaluate safety, tolerability, and pharmacokinetics of BEA 2180 BR in Japanese healthy volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Number of subjects with abnormal findings in physical examination
Time frame: up to 28 days after last dose administration
Number of subjects with clinically significant changes in vital signs
Blood pressure and pulse rate
Time frame: up to 28 days after last dose administration
Number of subjects with clinically significant changes in 12-lead electrocardiogram (ECG)
Time frame: up to 28 days after last dose administration
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 28 days after last dose administration
Number of subjects with adverse events
Time frame: up to 28 days after last dose administration
Assessment of tolerability by the investigator on a 4-point scale
Time frame: 28 days after last dose administration
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 648:00 hours
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Time frame: up to 648:00 hours
AUCτ (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ)
Time frame: up to 648:00 hours
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz)
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Time frame: up to 648:00 hours
Aeτ (amount of analyte that is eliminated in urine over a uniform dosing interval τ)
Time frame: up to 648:00 hours
feτ (fraction of analyte eliminated in urine over a uniform dosing interval τ)
Time frame: up to 648:00 hours
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Time frame: up to 648:00 hours
Cmin,ss (minimum concentration of the analyte in plasma at steady state)
Time frame: up to 648:00 hours
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
Time frame: up to 648:00 hours
λz,ss (terminal rate constant in plasma at steady state)
Time frame: up to 648:00 hours
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Time frame: up to 648:00 hours
MRTih,ss (mean residence time of the analyte in the body at steady state after inhalation administration)
Time frame: up to 648:00 hours
CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration)
Time frame: up to 648:00 hours
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
Time frame: up to 648:00 hours
Accumulation ratio of the analyte in plasma based on Cmax (RA,Cmax)
Time frame: up to 648:00 hours
Accumulation ratio of the analyte in plasma based on AUC (RA,AUC)
Time frame: up to 648:00 hours
Accumulation ratio of the analyte in plasma based on Ae (RA,Ae)
Time frame: up to 648:00 hours