Table 5.
PK Parameters in Patients with Various Degrees of Hepatic Impairment
| Index | Unit | Total (n=24) | Normal Liver Function (n=13) | Mild Liver Dysfunction (n=5) | Moderate/Severe Liver Dysfunction (n=6) |
|---|---|---|---|---|---|
| AUC(0→12h) | h·ng/mL | 452.53±121.11 | 488.54±137.03 | 436.59±79.64 | 387.77±93.13 |
| AUC(0→∞) | h·ng/mL | 479.10±117.88 | 509.12±133.9 | 459.58±75.66 | 430.32±103.57 |
| T1/2 | h | 2.85±0.99 | 2.66 (1.93–2.77) | 2.71 (2.57–2.89) | 3.54 (2.64–4.66)* |
| Cmax | ng/mL | 332.8±129.63 | 337.1 (250.25–391.9) | 280 (262.4–376.85) | 288.05 (264.23–311.58) |
| Tmax | h | 0.05 | 0.05 | 0.05 | 0.05 |
| CL | L/h | 33.42±9.4 | 27.4 (26.15–38.89) | 29.93 (28.96–39.7) | 35.62 (29.66–42.16) |
| Vd | L | 137.69±57.91 | 100.08 (74.51–153.86) | 112.63 (109.23–165.19) | 184.95 (147.58–231.52)* |
| MRT(0→12h) | h | 3.01±0.47 | 2.91±0.51 | 2.99±0.43 | 3.24±0.38 |
| MRT(0→∞) | h | 3.78±1.07 | 3.41±0.65 | 3.63±0.34 | 4.68±1.67* |
Notes: * P<0.05, compared to control group with normal liver function. Values are expressed as mean ± SD or median (IQR).
Abbreviations: AUC, area under the concentration–time curve; MRT, mean residence time; T1/2, elimination half-life; Cmax, maximum concentration; Tmax, time of peak concentration; CL, total clearance; Vd, the apparent volume of distribution.