The objective of the present study was to obtain information about safety, tolerability and pharmacokinetics of BIBN 4096 BS after oral administration of increasing doses in healthy male and female volunteers. With respect to pharmacokinetics, it was of particular importance to investigate whether therapeutic plasma levels (for treatment of migraine) could have been achieved by oral administration of a BIBN 4096 BS formulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Number of patients with adverse events
Time frame: up to 24 days
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 8 days after drug administration
Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)
Time frame: up to 8 days after drug administration
Number of patients with clinically significant changes in 12-lead Electrocardiogram (ECG)
Time frame: up to 8 days 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 24 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 24 hours after drug administration
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 24 hours after drug administration
CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
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
MRTtot (Total mean residence time of the analyte in plasma)
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Time frame: up to 24 hours after drug administration
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
Time frame: up to 24 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 24 hours after drug administration
Terminal rate constant in plasma
Time frame: up to 24 hours after drug administration