Table I.
Predicted Mean, Minimum, and Maximum PK Parameters of Compound B from Population Simulations of Three Controlled-Release Formulations with Different Release Rates, Under Fasted Condition
| Formulation | AUC0–24 h
(min, max) (μg×h/mL) |
C
max
(min, max) (μg/mL) |
T
max
(min, max) (h) |
Fa (min, max) (%) |
C
24 h
(min, max) (μg/mL) |
|---|---|---|---|---|---|
| 80% released in 8 h | 1.74 (0.65, 3.65) |
0.135 (0.058, 0.242) |
7.0 (5.1, 10.3) |
90 (76, 93) |
0.031 (0.020, 0.041) |
| 80% released in 12 h | 1.67 (0.64, 3.51) |
0.099 (0.055, 0.210) |
9.1 (4.1, 13.3) |
89 (75, 91) |
0.042 (0.032, 0.055) |
| 80% released in 16 h | 1.52 (0.58, 3.20) |
0.086 (0.043, 0.123) |
10.2 (4.3, 15.7) |
81 (70, 95) |
0.049 (0.036, 0.059) |
AUC area under the curve, Fa fraction absorbed