Safety, tolerability and pharmacokinetics of BIII 890
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
73
Number of patients with clinically relevant changes in vital signs
blood pressure, pulse rate, respiratory rate, body temperature
Time frame: Pre-dose, up to 8 days after drug administration
Number of subjects with clinically relevant changes in 12-lead ECG
Time frame: Pre-dose, up to 8 days after drug administration
Number of subjects with clinically relevant changes in laboratory parameters
including coagulation parameters
Time frame: Pre-dose, up to 8 days after drug administration
Number of subjects with adverse events
Time frame: Up to 8 days after drug administration
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: up to 32 hours after start of drug administration
Time from dosing to the maximum concentration of the analyte in plasma over a uniform dosing interval λz (tmax)
Time frame: up to 32 hours after start of drug administration
Apparent terminal half-life of the analyte in plasma (t1/2)
Time frame: up to 32 hours after start of drug administration
Area under the concentration-time curve of the analyte in plasma (AUC)
Time frame: up to 32 hours after start of drug administration
Mean residence time (MRT)
Time frame: up to 32 hours after start of drug administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Plasma clearance (CL)
Time frame: up to 32 hours after start of drug administration
Volume of distribution (V)
Time frame: up to 32 hours after start of drug administration
Amount of parent drug excreted into urine (Ae)
Time frame: up to 32 hours after start of drug administration