TABLE 7.
Values of VEL plasma PK parameters following administration with or without food
| Meal type and PK parameter | Value for the following treatmenta: |
% GLSMb ratio (90% CI) for test value/reference value | |
|---|---|---|---|
| 100 mg, fed (n = 12) | 100 mg, fasted (n = 12) | ||
| Light meal | |||
| AUCinf (ng · h/ml) | 7,120 (30.2) | 5,980 (40.8) | 125 (110, 141) |
| Cmax (ng/ml) | 800 (19.3) | 624 (34.3) | 135 (117, 156) |
| Tmax (h) | 3.25 (2.75, 4.25) | 2.50 (2.50, 3.00) | |
| t1/2 (h) | 16.7 (15.3, 18.2) | 17.0 (14.5, 18.3) | |
| High-fat, high-calorie meal | |||
| AUCinf (ng · h/ml) | 3,620 (48.0) | 4,130 (42.6) | 86.3 (73.4, 101) |
| Cmax (ng/ml) | 398 (42.2) | 526 (40.2) | 75.0 (62.6, 90.0) |
| Tmax (h) | 3.50 (2.75, 5.00) | 2.50 (2.50, 3.25) | |
| t1/2 (h) | 14.2 (11.8, 15.9) | 13.9 (11.6, 16.1) | |
a
All PK parameter values are reported as mean (percent coefficient of variation), except for Tmax and t1/2, which are reported as the median (quartile 1, quartile 3).
b
GLSM, geometric least-squares mean.