The objective of the present study was to obtain information about safety, tolerability and pharmacokinetics of BIBN 4096 BS after single subcutaneous administration of increasing doses in healthy male and female volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12
Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)
Time frame: up to 8 days after treatment day
Number of patients with clinically significant changes in 12-lead Electrocardiogram (ECG)
Time frame: up to 8 days after treatment day
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 8 days after treatment day
Number of patients with adverse events
Time frame: up to 24 days
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
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 48 hours after drug administration
Ae (Amount of drug excreted into urine)
Time frame: up to 48 hours after drug administration
tmax (Time from dosing to the maximum concentration of the analyte 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)
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Time frame: up to 48 hours after drug administration
MRT (Mean time of residence of drug 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
CL(R) (Renal clearance of the analyte in plasma)
Time frame: up to 48 hours after drug administration