Table 4.
PK parameters of AD16 (20 mg) in FE arm
| PK parameters | Fasted (N = 16) |
Fed (N = 16) |
|---|---|---|
| Tmax (h) | 0.87 (0.50–2.00) | 2.00 (0.50–4.00) |
| T1/2z (h) | 7.41 ± 2.02 (27.23) | 7.19 ± 2.02 (28.04) |
| Cmax (ng/mL) | 560.60 ± 124.96 (22.29) | 403.10 ± 89.63 (22.23) |
| AUC0-t (h*ng/mL) | 4143.77 ± 931.63 (22.48) | 4154.41 ± 1286.46 (30.97) |
| AUC0-∞ (h*ng/mL) | 4224.51 ± 981.28 (23.23) | 4263.01 ± 1338.75 (31.40) |
| AUC_%Extrap (%) | 1.81 ± 1.57 (84.94) | 2.56 ± 1.70 (66.69) |
| CL/F (mL/h) | 4976.05 ± 1139.73 (22.90) | 5153.49 ± 1683.51 (32.67) |
| Vd/F (mL) | 50,548.34 ± 6031.25 (11.93) | 49,778.22 ± 7718.92 (15.51) |
| λz (1/h) | 0.10 ± 0.03 (25.31) | 0.10 ± 0.03 (25.66) |
| MRT0-t (h) | 8.64 ± 1.94 (22.44) | 9.65 ± 2.41 (24.99) |
| MRT0-∞ (h) | 9.41 ± 2.40 (25.52) | 10.61 ± 2.70 (25.44) |
Data are expressed as mean ± SD (CV%) unless otherwise specified. Tmax (h) is expressed as median (range)