The objective of this study is to investigate if the systemic drug exposure of at least 25 μg and perhaps 50 μg salmeterol presented as inhalation powder in PE capsules and administered via HandiHaler® 2 does not exceed that of 50 μg Serevent® Diskus® and to investigate safety and tolerability of salmeterol presented as inhalation powder in PE capsules and administered via HandiHaler® 2
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
AUC0-∞ (area under the concentration-time curve of salmeterol in blood plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 8 hours after drug administration
Cmax (maximum measured concentration of salmeterol in blood plasma)
Time frame: up to 8 hours after drug administration
AUC0-tz (area under the concentration-time curve of salmeterol in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: up to 8 hours after drug administration
AUCt1-t2 (area under the concentration time curve of salmeterol in plasma over the time interval t1 to t2)
Time frame: up to 8 hours after drug administration
tmax (time from dosing to the maximum concentration of salmeterol in plasma)
Time frame: up to 8 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: up to 8 hours after drug administration
t½ (terminal half-life of salmeterol in plasma)
Time frame: up to 8 hours after drug administration
MRTih (mean residence time of salmeterol in the body after inhalational administration)
Time frame: up to 8 hours after drug administration
CL/F (apparent clearance of salmeterol in the plasma after extravascular administration)
Time frame: up to 8 hours after drug administration
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Vz/F (apparent volume of distribution during the terminal phase (λz) following an extravascular dose)
Time frame: up to 8 hours after drug administration
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 14 days following the last drug administration
Number of patients with clinically significant changes in vital signs
Blood Pressure, Pulse Rate
Time frame: up to 14 days following the last drug administration
Number of patients with clinically significant changes in 12-lead ECG parameters
Time frame: up to 14 days following the last drug administration
Number of patients with adverse events
Time frame: up to 14 days following the last drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: 14 days following the last drug administration