Table 3.
Pharmacokinetic and PD Characteristics of BIOD-090, BIOD-100, and LIS.
| Variables | BIOD-100 | BIOD-090 | LIS | BIOD-100 vs LIS median difference / ratio (90% CI) |
|---|---|---|---|---|
| PK | ||||
| T50%-early (min)a | 7.7 / 7.9 (3.0) | 9.7 / 9.8 (3.8) | 21.6 / 23.3 (6.3) | -15.5c(-17.3; -13.8) |
| Tmax (min)a | 20.0 / 29.4 (29.3) | 27.5 / 31.6 (15.7) | 60.0 / 57.1 (21.8) | -30.0c(-35.0; -22.5) |
| T50%-late (min)a | 135.6 / 142.9 (78.5) | 131.4 / 141.6 (62.1) | 130.2 / 136.0 (41.3) | 6.9 (-14.9; 26.8) |
| PD | ||||
| tGIR50%-early (min)a | 24.2 / 27.8 (18.2) | 23.5 / 28.4 (17.5) | 44.3 / 45.4 (20.1) | -17.9c(-25.6; -10.4) |
| tGIRmax (min)a | 132.0 / 137.8 (74.7) | 75.0 / 99.3 (53.9) | 114.0 / 118.8 (49.5) | 20.0 (-3.0; 43.0) |
| tGIR50%-late (min)a | 276.1 / 285.3 (80.6) | 252.0 / 249.8 (66.0) | 227.9 / 234.2 (56.7) | 49.6c(24.6; 72.7) |
| tGIR10%AUC (min)a | 46.1 / 47.0 (14.2) | 42.2 / 45.3 (13.6) | 52.0 / 52.7 (15.6) | -5.3c(-10.5; -0.8) |
| GIRmax (mg/kg/min)b | 6.0 / 6.1 (0.37) | 6.0 / 6.3 (0.38) | 6.7 / 6.6 (0.38) | 0.93 (0.86; 1.01) |
| AUCGIR0-60 (mg/kg)b | 210 / 176 (0.77) | 239 / 191 (0.68) | 150 / 111 (1.24) | 1.65c(1.27; 2.14) |
Pharmacokinetic:
a
Median and arithmetic mean (SD) plus median differences with 90% CI, or
b
Median and geometric mean (SD of log) plus ratios with 90% CI.
a
p < .10 BIOD-100 vs LIS.