Table 3. Summary of PK parameters of perampanel after single-dose administrations of 4-mg fine granules and 4-mg tablet (PK analysis set).
| PK parameter | 4-mg fine granules (N = 21) |
4-mg tablet (N = 21) |
|---|---|---|
| Cmax (ng/mL) | ||
| Mean (SD) | 152 (28.3) | 154 (42.6) |
| Geometric mean (CV%) | 149 (19.9) | 149 (28.5) |
| AUC(0–168h) (ng×h/mL) | ||
| Mean (SD) | 5,770 (1,340) | 5,620 (1,600) |
| Geometric mean (CV%) | 5,630 (22.9) | 5,420 (27.8) |
| AUC(0–inf) (ng×h/mL) | ||
| Mean (SD) | 8,040 (2,750) | 8,000 (3,770) |
| Geometric mean (CV%) | 7,610 (35.5) | 7,320 (43.6) |
| tmax (h), median (min, max) | 0.75 (0.50, 3.00) | 0.75 (0.50, 2.00) |
| T1/2 (h) | ||
| Mean (SD) | 87.9 (32.4) | 89.5 (49.4) |
| Geometric mean (CV%) | 81.8 (41.2) | 78.2 (56.7) |
AUC(0–168h) = area under the concentration–time curve from time zero to 168 hours; AUC(0–inf) = area under the concentration–time curve from time zero extrapolated to infinity; Cmax = maximum observed concentration; CV% = percent coefficient of variation; h = hours; PK = pharmacokinetic; max = maximum; min = minimum; SD = standard deviation; tmax = time at which the highest drug concentration occurs; T1/2 = terminal elimination phase half-life.