The objective of the present study is to obtain information about the safety and tolerability of multiple increasing doses of BIIX 1 XX and to obtain preliminary pharmacokinetic data
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
8
Number of subjects with adverse events
Time frame: up to day 28
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to day 21
Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate)
Time frame: up to day 21
Number of subjects with clinically significant changes in ECG (Electrocardiogram)
Time frame: up to 21 days
AUC (Total Area under the plasma drug concentration time curve)
Time frame: up to 336 hours after last drug administration
Cmax (maximum observed concentration of the analyte in plasma)
Time frame: up to 336 hours after last drug administration
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 336 hours after last drug administration
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 336 hours after last drug administration
MRT (mean time of residence of drug molecules in the body )
Time frame: up to 336 hours after last drug administration
CL (Total clearance of the analyte in plasma following extravascular administration)
Time frame: up to 336 hours after last drug administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.