Table 5.
Geometric Mean Ratioa (and 90%CI) of Pharmacokinetic Parameters for Subjects With Hepatic Impairment Versus Healthy Subjects With Normal Hepatic Function
| Hepatic Impairment Study | ||
|---|---|---|
| Mild | Moderate | |
| AUC0‐t | 82.7 (65.5, 104.5) | 104.7 (82.9, 132.3) |
| AUC0‐inf | 82.8 (65.7, 104.5) | 105.2 (83.4, 132.6) |
| Cmax | 90.0 (68.6, 118.0) | 107.8 (82.3, 141.4) |
| t½,z | 103.7 (90.4, 119.0) | 98.5 (85.9, 113.0) |
AUC0‐t indicates area under the plasma concentration‐time curve from time 0 to the time of the last quantifiable concentration after dosing; AUC0‐inf, area under the plasma concentration‐time curve extrapolated from time 0 to infinity; Cmax, maximum observed plasma concentration; t½,z, terminal elimination half‐life.
a
The ratio for mild or moderate hepatic impairment compared with healthy subjects with normal hepatic function (ie, hepatic impairment/normal function × 100).