The objective of the present study is to obtain information about the safety, tolerability and pharmacokinetics of BIBN 4096 BS after single intravenous administration of increasing doses in healthy male and female volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
55
Number of subjects with adverse events
Time frame: up to 2 months
Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate, respiratory rate)
Time frame: up to 8 days after last study day
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 8 days after last study day
Number of subjects with clinically relevant changes in venous-occlusion plethysmography
Time frame: up to 8 hours after drug administration
Number of subjects with clinically significant changes in ECG (Electrocardiogram)
Time frame: up to 8 days after last study day
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 24 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 24 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 24 hours after drug administration
MRT (Mean residence time of the analyte in the body)
Time frame: up to 24 hours after drug administration
CL (Total clearance of the analyte in plasma following extravascular administration)
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Time frame: up to 24 hours after drug administration
Vz (Apparent volume of distribution during the terminal elimination phase)
Time frame: up to 24 hours after drug administration
Vss (Volume of distribution at steady state)
Time frame: up to 24 hours after drug administration
Percentage of urinary excretion of BIBN 4096 BS
Time frame: up to 24 hours after drug administration