The objective of the present study is to obtain information about the safety, tolerability and pharmacokinetics of BIBN 4096 BS after single inhalative administration of increasing doses in healthy male and female volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Number of patients with adverse events
Time frame: up to 24 days
Change in lung function measurement specific conductance (SGaw)
Time frame: up to 5 hours after drug administration
Assessment of tolerability on a 4-point scale
Time frame: 8 days after drug administration
Change in lung function measurement airway resistance (Raw)
Time frame: up to 5 hours after drug administration
Number of patients with clinically relevant changes in Blood Pressure
Time frame: up to 24 days
Number of patients with clinically relevant changes in Pulse Rate
Time frame: up to 24 days
Number of patients with clinically relevant changes in Electrocardiogram
Time frame: up to 24 days
Number of patients with clinically relevant changes in standard laboratory evaluation
Time frame: up to 24 days
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 48 hours after drug administration
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 48 hours after drug administration
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tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 48 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 last quantifiable data point)
Time frame: up to 48 hours after drug administration
λz (Terminal rate constant in plasma)
Time frame: up to 48 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 48 hours after drug administration
CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
Time frame: up to 48 hours after drug administration
MRTtot (Total mean residence time of the analyte molecules in the body)
Time frame: up to 48 hours after drug administration
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
Time frame: up to 48 hours after drug administration
CLR (Renal clearance of the analyte in plasma)
Time frame: up to 48 hours after drug administration
Ae (Amount of parent drug excreted into urine)
Time frame: up to 24 hours after drug administration