To assess the pharmacokinetics of midazolam with/without concomitant administration of crobenetine
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Area under the concentration-time curve of midazolam from zero time extrapolated to infinity (AUC0-infinity)
Time frame: up to 24 hours after start of drug administration
Maximum observed concentration of midazolam in plasma (Cmax)
Time frame: up to 24 hours after start of drug administration
Area under the concentration-time curve (AUC)
Time frame: up to 24 hours after start of drug administration
Time to maximum observed concentration (tmax)
Time frame: up to 24 hours after start of drug administration
Individual time courses of plasma concentrations
Time frame: up to 24 hours after start of drug administration
Terminal rate constant in plasma (λz)
Time frame: up to 24 hours after start of drug administration
Terminal half-life in plasma (t1/2)
Time frame: up to 24 hours after start of drug administration
Mean residence time in the body (MRT)
Time frame: up to 24 hours after start of drug administration
Apparent clearance in plasma (CL/F)
Time frame: up to 24 hours after start of drug administration
Volume of distribution (V)
Time frame: up to 24 hours after start of drug administration
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Changes from baseline in physical examination
Time frame: pre-dose and day 8 after drug administration
Number of patients with clinically relevant findings in vital signs
blood pressure, pulse rate
Time frame: up to day 8 after drug administration
Number of patients with clinically relevant findings in 12-lead ECG
Time frame: up to day 8 after drug administration
Number of patients with clinically relevant findings in laboratory tests
Time frame: up to day 8 after drug administration
Number of patients with adverse events
Time frame: up to day 8 after drug administration
Global assessment of tolerability by the investigator on a 4-point rating scale
Time frame: up to 192 hours after start of drug administration