The objective of the present study was to obtain information about the safety, tolerability and pharmacokinetics of BIIR 561 CL after continuous intravenous administration of two increasing doses in healthy elderly volunteers, following the infusion schema of a loading dose (1 hour) and a maintenance dose (5 hours)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
13
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 drug plasma concentration (Cmax)
Time frame: up to 32 hours after first drug administration
Time to Cmax (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
Mean residence time (MRT)
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Time frame: up to 32 hours after first drug administration
Plasma clearance (CL)
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