Safety, tolerability and pharmacokinetics
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Number of patients with clinically relevant findings in vital signs
blood pressure, pulse rate
Time frame: up to 8 days after drug administration
Number of patients with clinically relevant findings in 12-lead ECG
Time frame: up to 8 days after drug administration
Number of patients with adverse events
Time frame: up to 8 days after drug administration
Number of patients with clinically relevant findings in laboratory parameters
Time frame: up to 8 days after drug administration
Changes in rhinoscopy assessment
Time frame: up to 8 days after drug administration
Maximum measured concentration in plasma (Cmax)
Time frame: up to 48 hours after drug administration
Time from dosing to the maximum concentration in plasma (tmax)
Time frame: up to 48 hours drug administration
Area under the concentration-time curve in plasma (AUC)
Time frame: up to 48 hours after drug administration
Terminal rate constant of in plasma (λz)
Time frame: up to 48 hours after drug administration
Apparent terminal half-life in plasma (t1/2)
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.
Total mean residence time in the body (MRTtot)
Time frame: up to 48 hours after drug administration
Total clearance in plasma after extravascular administration (CL/F)
Time frame: up to 48 hours after drug administration
Apparent volume of distribution during the terminal phase (Vz/F)
Time frame: up to 48 hours after drug administration
Amount excreted into urine (Ae)
Time frame: up to 48 hours after drug administration
Renal clearance (CLR)
Time frame: up to 48 hours after drug administration
Assessment of dose-proportionality of epinastine nasal
based on AUC and Cmax
Time frame: up to 48 hours after drug administration