TABLE 3.
Steady-state pharmacokinetics of silybin A and silybin B
Results are shown as geometric mean (95% confidence interval), except for Tmax, which is shown as median (minimum, maximum). Data are for n = 6 subjects, except for the HCV 560-mg steady-state cohort where n = 5; one subject was dropped from the pharmacokinetic analysis because of incorrect dosing for pharmacokinetic sampling at steady-state on day 8.
| Cohort | PK Parameter | SA |
SB |
||
|---|---|---|---|---|---|
| HCV | NAFLD | HCV | NAFLD | ||
| 280 mg | AUC0–8 h (ng · h/ml) | 370 (279–480) | 317 (191–499) | 86 (66–109) | 123 (53–219)a |
| Cmax (ng/ml) | 143 (78–242) | 133 (60–262) | 45 (28–72) | 64 (30–111)a | |
| Tmax (h) | 1.8 (1.0, 4.0) | 1.3 (0.5, 4.4) | 1.5 (0.5, 4.0) | 1.2 (0.5, 2.0)a | |
| t1/2 (h) | 1.1 (0.7–1.6) | 1.1 (0.3–2.6) | 0.7 (0.4–1.2)a | 0.9 (0.2–2.1)a | |
| 560 mg | AUC0–8 h (ng · h/ml) | 729 (371–1195) | 1166 (589–2128) | 149 (40–310) | 376 (161–759) |
| Cmax (ng/ml) | 308 (104–620) | 448 (255–724) | 86 (26–186) | 187 (93–332) | |
| Tmax (h) | 1.5 (1.5, 2.0) | 3.0 (0.5, 4.0) | 1.5 (1.5, 2.0) | 3 (0.5, 4.0) | |
| t1/2 (h) | 1.3 (0.9–1.9) | 1.0 (0.6–1.6) | 1.1 (0.3–2.2) | 0.7 (0.4–1.0) | |
SA, silymarin A; SB, silymarin B.
a
n = 5.