The purpose of the present study was to obtain information about the safety, tolerability and pharmacokinetics of BIBN 4096 BS after single inhalation administration of rising doses of spray-dried powder in healthy male and female volunteers. According to the original protocol, the primary objective was to investigate the safety and tolerability of single doses of a new spray-dried inhalation formulation of BIBN 4096 BS (SD I). Following implementation of Amendment 2, this objective was extended to the second spray-dried inhalation formulation SD II with and without concomitant administration of lactose
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
63
Number of patients with adverse events
Time frame: up to 25 days
Assessment of tolerability on a 4-point scale
Time frame: 8 days after drug administration
Change in lung function measurements airway resistance (Raw)
Time frame: up to 5 hours after drug administration
Change in lung function measurement specific conductance (SGaw)
Time frame: up to 5 hours after drug administration
Change in lunf function measurement forced expiratory volume in 1 second (FEV1)
Time frame: up to 5 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)
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
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
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
MRTih (Mean residence time of the analyte in the body after inhalation)
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
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
Time frame: up to 48 hours after drug administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.