Table 8.
Parameters a | NBCoV1 | NBCoV2 | UNITS | ||
---|---|---|---|---|---|
PO | IV | PO | IV | ||
Dose | 10 | 5 | 10 | 5 | mg/kg |
t1/2 | 11.32 | 3.57 | 3.96 | 3.52 | h |
Tmax | 2 | 0.25 | 4 | 2 | h |
Cmax | 1499.76 | 7815.76 | 30.12 | 2219.45 | ng/mL |
C0 | - | 7407.25 | - | 1710.87 | ng/mL |
AUC0-t | 12,023.00 | 37,515.91 | 318.78 | 18,074.45 | ng/mL ∗ h |
MRT0-inf_obs | 14.34 | 4.02 | 7.28 | 5.09 | h |
CLobs | - | 0.00013 | - | 0.00027 | (mg/kg)/(ng/mL)/h |
Vss_obs | - | 0.00053 | - | 0.00140 | (mg/kg)/(ng/mL) |
Vz/F_obs | 0.01078 | - | 0.17593 | - | (mg/kg)/(ng/mL) |
CL/F_obs | 0.00066 | - | 0.03082 | - | (mg/kg)/(ng/mL)/h |
F% | 20.1 | - | 0.9 | - | 100 ∗ AUC(PO)/AUC(IV) |
a A single oral (PO) or IV dose; t1/2, apparent terminal elimination half-life; tmax, time to peak concentration; Cmax, maximum measured plasma concentration; C0, initial measured plasma concentration; AUC, area under the concentration time curve; MRT, mean residence time; CL, clearance rate of the analyte (IV only); Vss, volume of distribution of the analyte in the test system estimated at steady state (IV only); VZ/F, apparent volume of distribution; CL/F, apparent oral clearance; F%, bioavailability, represents the fraction of a dose reaching systemic circulation intact; i.e., fraction of dose absorbed.