1. To compare the systemic drug exposure of 100 μg Serevent ® Diskus ® with that of 50 μg Serevent ® MDI with sufficient precision so that in combination with a second trial it can be demonstrated that the systemic drug exposure of a new formulation of salmeterol xinafoate is not superior to that of Serevent ® MDI 2. To test a system of ordered null hypotheses regarding the exposure of two dose levels of Serevent ® Diskus ® and Serevent ® MDI 3. To get data about the systemic drug exposure of 25 μg Serevent ® MDI and of 50 μg Serevent ® Diskus ®
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: Up to 6 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: Up to 6 hours after drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: Up to 6 hours after drug administration
AUCt1-t2 (Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)
Time frame: Up to 6 hours after inhalation
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: Up to 6 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: Up to 6 hours after drug administration
t½ (terminal half-life of the analyte in plasma)
Time frame: Up to 6 hours after drug administration
MRTinh (mean residence time of the analyte in the body after inhalational administration)
Time frame: Up to 6 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: Up to 6 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: Up to 6 hours after drug administration
Aet1-t2 (amount of analyte that was eliminated in urine from the time interval t1 to t2)
Time frame: Up to 6 hours after inhalation
fet1-t2 (fraction of administered drug excreted unchanged in urine from time point t1 to t2)
Time frame: Up to 6 hours after inhalation
CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 to t2)
Time frame: Up to 6 hours after inhalation
Number of participants with abnormal findings in physical examination
Time frame: Up to 15 days after last drug administration
Number of participants with clinically significant changes in vital signs
Time frame: Up to 15 days after last drug administration
Number of participants with abnormal findings in ECG
Time frame: Up to 15 days after last drug administration
Number of participants with abnormal changes in clinical laboratory parameters
Time frame: Up to 15 days after last drug administration
Number of participants with adverse events
Time frame: Up to 15 days after last drug administration
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