Table 8:
Normalized PK Parameters to GW Pharmaceuticals’ PopPK model (1500 mg)
| Data points | Dose-normalized Cmax (ng/mL) | Tmax (hrs) | Dose-normalized AUC(0-∞) (h*ng/mL) |
|---|---|---|---|
|
| |||
| Predicted Fasted | 335.4 | 3.5 | 2198 |
| Predicted Fed | 1628 | 3 | 8669 |
|
| |||
| A1 | 672.4 | 5.12 | 3366.6 |
| A2 | 524.5 | 6.13 | 2713 |
| A3 | 142.3 | 4.07 | 763.43 |
| B1 | 840 | 5 | - |
| B2 | 852 | 4.5 | - |
| B3 | 838 | 5 | - |
| C | 146.063 | 3 | - |
| D1 | 75 | 1 | 465 |
| D2 | 315 | 3 | 1035 |
| E1 | 679.5 | 3 | 26400 |
| E2 | 414.56 | 3 | 16256.25 |
| F1 | 375 | 1.63 | 64099.5 |
| F2 | 453 | 2.8 | 61168.5 |
| F3 | 391.5 | 2.05 | 74547 |
| F4 | 370.5 | 1.27 | 54306 |
| G | 810 | 1.38 | - |
| H1 | 292.4 | 4 | 1618 |
| H2 | 266.5 | 5 | 1401 |
| H2 | 240.7 | 5 | 1154 |
| H4 | 195.5 | 5 | 975 |
| H5 | 335.4 | 3.5 | 2198 |
| H6 | 1628 | 3 | 8669 |
| H7 | 581.6 | 3 | - |
| H8 | 361.8 | 3 | - |
| I2 | 560 | 1.88 | 75066.67 |
| I2 | 910 | 2.05 | 118583.33 |
| I3 | 706.67 | 2.17 | 95333.33 |
| I4 | 1293.33 | 1.83 | 181083.33 |
| J1 | 483 | 3 | 1546.5 |
| J2 | 711.6 | 3.5 | 2295.6 |
| J3 | 307.5 | 3.5 | 1171.5 |
| K1 | 117 | 1 | 498 |
| K2 | 172.5 | 1.38 | 846 |
| K3 | 162.75 | 1 | 996 |
| K4 | 147 | 1.64 | - |
| K5 | 171 | 1.27 | - |
| K6 | 241.5 | 2 | - |
| L1 | 1747.5 | 2.8 | 5242.5 |
| L2 | 2655 | 2 | 8722.5 |
| L3 | 2857.5 | 2.5 | 18292.5 |
| L4 | 1110 | 2.33 | 3555 |
| M1 | 45 | 3.2 | 795 |
| M2 | 675 | 2.4 | 3855 |
| N | 499.5 | 4.22 | 6466140 |
Dose- and patient weight-normalized values correspond to the Population Pharmacokinetic (PopPK) plot generated by GW Pharmaceuticals