The objective of the present study is to obtain information about the safety, tolerability and pharmacokinetics of BIIR 561 after continuous intravenous administration of increasing doses in healthy young volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Number of subjects with adverse events
Time frame: up to 8 days after drug administration
Number of subjects with clinically significant findings in vital functions
blood pressure, pulse rate, respiratory rate, oral body temperature
Time frame: up to 8 days after drug administration
Number of subjects with clinically significant findings in ECG
Time frame: up to 8 days after drug administration
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 8 days after drug administration
Maximum concentration in plasma (Cmax)
Time frame: up to 32 hours after first drug administration
Time to maximum concentration in plasma (tmax)
Time frame: up to 32 hours after first drug administration
Terminal half-life (t1/2)
Time frame: up to 32 hours after first drug administration
Area under the plasma concentration-time curve from zero to the last time points with a quantifiable plasma concentration (AUC0-tf)
Time frame: up to 32 hours after first drug administration
Area under the plasma concentration-time curve extrapolated to infinity (AUC0-inf)
Time frame: up to 32 hours after first drug administration
Total Mean residence time (MRTtot)
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Time frame: up to 32 hours after first drug administration
Total plasma clearance (CLtot)
Time frame: up to 32 hours after first drug administration
Volume of distribution (Vz)
Time frame: up to 32 hours after first drug administration
Volume of distribution at steady state (Vss)
Time frame: up to 32 hours after first drug administration
Amount excreted into urine (Ae)
Time frame: up to 32 hours after first drug administration
Mean residence time of disposition (MRTdisp)
Time frame: up to 32 hours after first drug administration
Renal clearance (CLR)
Time frame: up to 32 hours after first drug administration