Table 3.
Plasma BNZ-1 Pharmacokinetic Parameters Following a Single Intravenous Infusion
Pharmacokinetic Parameters | BNZ-1 Dose Group | |||||
---|---|---|---|---|---|---|
0.2 mg/kg (n = 3) | 0.4 mg/kg (n = 3) | 0.8 mg/kg (n = 3) | 1.6 mg/kg (n = 3) | 3.2 mg/kg (n = 3) | 6.4 mg/kg (n = 3) | |
AUC0-t (μg • h/mL) | 934 (35.7) | 1780 (42.0) | 4140 (22.4) | 1170 (13.1) | 19 600 (2.9) | 45 900 (21.6) |
AUC0-inf (μg • h/mL) | 1280 (31.0) | 2260 (29.4) | 4450 (19.1) | 12 200 (14.1) | 20 100 (2.4) | 46 700 (21.4) |
AUC%extrap | 26.3 ± 12.0 | 21.1 ± 9.38 | 6.90 ± 3.32 | 3.87 ± 1.47 | 2.44 ± 0.613 | 1.62 ± 0.870 |
Cmax (μg/mL) | 9.91 (22.9) | 17.6 (6.5) | 31.4 (30.9) | 101 (4.3) | 153 (17.8) | 386 (43.0) |
tmax (h) | 0.115 (0.100, 0.140) | 0.105 (0.104, 1.02) | 2.02 (2.02, 2.06) | 2.02 (1.88, 2.08) | 0.173 (0.165, 2.11) | 0.173 (0.166, 2.08) |
Kel (1/h) | 0.00658 ± 0.000960 | 0.00663 ± 0.00196 | 0.00599 ± 0.000542 | 0.00622 ± 0.000990 | 0.00557 ± 0.00148 | 0.00539 ± 0.000780 |
t1/2 (h) | 107 ± 15.5 | 112 ± 39.0 | 116 ± 10.9 | 113 ± 16.9 | 130 ± 31.7 | 130 ± 17.4 |
CL (mL/h) | 11.9 ± 2.92 | 13.3 ± 3.78 | 13.4 ± 1.86 | 12.3 ± 3.65 | 10.8 ± 2.47 | 13.5 ± 2.86 |
Vd (mL) | 1760 ± 309 | 1950 ± 290 | 2020 ± 179 | 1710 ± 474 | 1660 ± 135 | 2020 ± 95.5 |
AUC0-inf, area under the plasma concentration–time curve from time 0 to time of last measurable concentration; AUC0-t, area under the plasma concentration–time curve from time 0 to time of last measurable concentration; AUC%extrap, percentages of area under curve extrapolated to infinity; CL, clearance; Cmax, maximum observed plasma concentration; Kel, apparent terminal elimination rate constant; t1/2, terminal elimination half-life; tmax, time to maximum observed plasma concentration; Vd, volume of distribution.
AUCs and Cmax values are presented as geometric mean and geometric coefficient of variation.
Tmax values are presented as median (minimum, maximum). AUC%extrap, Kel, t1/2, CL, and Vd are presented as mean ± standard deviation.