Table 9:
Interindividual Variability of Normalized PK Parameters in GW Pharmaceuticals’ PopPK Model
| Drug | Cmax (ng/mL), (CV%) | Tmax (hrs), (CV%) | Dose-Normalized AUC(0-∞) (h*ng/mL), (CV%) | # Studies | Dose- and Weight-normalized RMSE | RMSE | Studies Included |
|---|---|---|---|---|---|---|---|
|
| |||||||
| Epidiolex | |||||||
| Fed | 1467 (52.66) | 3.28 (34.65) | 8056.08 (62.36) | 9 | 3.89 | 1166.37 | B1-B3, H6, L1-L4, M2 |
| Fasted | 332.55 (52.61) | 4.27 (23.25) | 1664.89 (51.65) | 11 | 8.14 | 250.86 | A1-A3, H1-H5, H7, H8, M1 |
| Sativex | |||||||
| Fed | 374 (23.74) | 3.57 (14.01) | 2156115.5 (141.35) | 3 | 0.49 | 73.38 | D2, J3, N |
| Fasted | 304.13 (66.53) | 1.62 (32.35) | 33692.5 (98.43) | 10 | 3.52 | 222.41 | F1-F3, G, K1-K6 |
| Oral Capsule | |||||||
| Fed | 597.97 (56.42) | 2.44 (29.96) | 57447.78 (105.16) | 10 | 0.99 | 297.34 | C, D1, E1, E2, I1-I4, J1, J2 |
| Fasted | 370.5 (0) | 1.27 (0) | 54306 (0) | 1 | 3.85 | 288.78 | F4 |
Mean dose- and patient weight-normalized values correspond to the PopPK plot created by GW Pharmaceuticals