Table 4:
Normalized Pharmacokinetic Parameters to 2.5 mg/kg for 75 kg
| Data Points | Raw Dose (mg) | Dose-normalized Dose (mg) | Dose-normalized Cmax (ng/mL) | Tmax (hrs) | Dose-normalized AUC(0-∞) (h*ng/mL) |
|---|---|---|---|---|---|
|
| |||||
| Predicted Fasted | 187.5 | 187.5 | 81.723 | 0.5 | - |
| Predicted Fed | 187.5 | 187.5 | 300.63 | 2.5 | - |
|
| |||||
| A1 | 750 | 187.5 | 84.05 | 5.12 | 420.83 |
| A2 | 1500 | 187.5 | 131.13 | 6.13 | 339.13 |
| A3 | 4500 | 187.5 | 106.73 | 4.07 | 95.43 |
| B1 | 1500 | 187.5 | 210 | 5 | - |
| B2 | 1500 | 187.5 | 213 | 4.5 | - |
| B3 | 1500 | 187.5 | 209.5 | 5 | - |
| C | 800 | 187.5 | 18.26 | 3 | - |
| D1 | 10 | 187.5 | 39.38 | 1 | 58 |
| D2 | 10 | 187.5 | 9.38 | 3 | 129 |
| E1 | 400 | 187.5 | 84.94 | 3 | 3300 |
| E2 | 800 | 187.5 | 51.82 | 3 | 2032 |
| F1 | 10 | 187.5 | 46.94 | 1.63 | 8012 |
| F2 | 10 | 187.5 | 56.63 | 2.8 | 7646 |
| F3 | 10 | 187.5 | 48.94 | 2.05 | 9318 |
| F4 | 10 | 187.5 | 46.31 | 1.27 | 6788 |
| G | 10 | 187.5 | 26.34 | 1.38 | - |
| H1 | 1500 | 187.5 | 36.55 | 4 | 202.25 |
| H2 | 3000 | 187.5 | 33.31 | 5 | 175.13 |
| H2 | 4500 | 187.5 | 30.09 | 5 | 142.75 |
| H4 | 6000 | 187.5 | 24.44 | 5 | 121.88 |
| H5 | 1500 | 187.5 | 41.93 | 3.5 | 274.75 |
| H6 | 1500 | 187.5 | 203.5 | 3 | 1083.63 |
| H7 | 750 | 187.5 | 82.58 | 3 | - |
| H8 | 1500 | 187.5 | 67.65 | 3 | - |
| I1 | 45 | 187.5 | 70 | 1.88 | - |
| I2 | 90 | 187.5 | 113.75 | 2.05 | - |
| I3 | 45 | 187.5 | 88.33 | 2.17 | - |
| I4 | 90 | 187.5 | 161.67 | 1.83 | - |
| J1 | 10 | 187.5 | 60.38 | 3 | 193.31 |
| J2 | 100 | 187.5 | 88.95 | 3.5 | 286.95 |
| J3 | 10 | 187.5 | 38.44 | 3.5 | 146.44 |
| K1 | 5 | 187.5 | 14.63 | 1 | 62.25 |
| K2 | 10 | 187.5 | 21.56 | 1.38 | 105.75 |
| K3 | 20 | 187.5 | 20.34 | 1 | 124.5 |
| K4 | 5 | 187.5 | 18.38 | 1.64 | - |
| K5 | 10 | 187.5 | 21.38 | 1.27 | - |
| K6 | 20 | 187.5 | 30.19 | 2 | - |
| L1 | 200 | 187.5 | 218.44 | 2.8 | 655.31 |
| L2 | 200 | 187.5 | 331.88 | 2 | 1090.31 |
| L3 | 200 | 187.5 | 357.19 | 2.5 | 2337.19 |
| L4 | 200 | 187.5 | 138.75 | 2.33 | 444.38 |
| M1 | 300 | 187.5 | 5.63 | 3.2 | 353.77 |
| M2 | 300 | 187.5 | 84.38 | 2.4 | 481.88 |
| N | 10 | 187.5 | 62.44 | 4.22 | 808267.5 |
Dose- and patient weight-normalized values correspond to the Population Pharmacokinetic (PopPK) plot generated by E.C. and transposed by A.W.