Table 5:
Normalized Pharmacokinetic Parameters to 2.5 mg/kg for 75 kg
| 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 | 218.51 (36.37) | 3.28 (34.64) | 1015.45 (63.54) | 9 | 0.41 | 82.12 | B1-B3, H6, L1-L4, M2 |
| Fasted | 58.55 (60.52) | 4.27 (23.25) | 236.21 (46.05) | 11 | 7.55 | 23.48 | A1-A3, H1-H5, H7, H8, M1 |
| Sativex | |||||||
| Fed | 36.75 (59.04) | 3.57 (14.01) | 404206.97 (99.96) | 3 | 0.98 | 263.88 | D2, J3, N |
| Fasted | 30.53 (46.03) | 1.62 (32.35) | 4211.42 (98.43) | 10 | 2.33 | 51.21 | F1-F3, G, K1-K6 |
| Oral Capsule | |||||||
| Fed | 77.75 (49.27) | 2.44 (29.96) | 240.13 (19.5) | 10 | 0.74 | 222.88 | C, D1, E1, E2, I1-I4, J1, J2 |
| Fasted | 46.31 (0) | 1.27 (0) | 6788 (0) | 1 | 1.6 | 35.42 | F4 |
Mean dose- and patient weight-normalized values correspond to the Population Pharmacokinetic (PopPK) plot generated by E.C. and transposed by A.W.