The objective of the present study is to obtain information about the safety, tolerability and pharmacokinetics of BIBN 4096 BS after single intranasal administration of increasing doses in healthy male and female volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Changes in nasal mucosa assessed by rhinoscopy
Time frame: up to 2 hours after treatment
Changes in nasal flow and resistance assessed by rhinomanometry
Time frame: up to 2 hours after treatment
Number of patients with adverse events
Time frame: up to 24 days
AUC (Area under the concentration-time curve of the analyte in plasma)
Time frame: up to 12 hours after intranasal administration
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 12 hours after intranasal administration
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 12 hours after intranasal administration
MRT (Mean residence time of the analyte in the body)
Time frame: up to 12 hours after intranasal administration
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 12 hours after intranasal administration
CL (systemic clearance)
Time frame: up to 12 hours after intranasal administration
Vd (Volume of distribution)
Time frame: up to 12 hours after intranasal administration
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