Table 3.
Geometric Mean Ratioa (and 90%CI) of Pharmacokinetic Parameters for Subjects With Renal Impairment Versus Healthy Subjects With Normal Renal Function
| Renal Impairment Study | ||||
|---|---|---|---|---|
| Mild | Moderate | Severe | ESRDb | |
| AUC0‐t | 107.4 | 103.8 | 132.6 | 82.3 |
| (90.8, 126.9) | (87.8, 122.7) | (110.7, 158.8) | (69.7, 97.3) | |
| AUC0‐inf | 107.7 | 106.0 | 137.8 | 82.8 |
| (90.4, 128.3) | (89.0, 126.4) | (114.0, 166.5) | (69.5, 98.6) | |
| Cmax | 88.7 | 75.5 | 81.3 | 82.9 |
| (73.5, 107.0) | (62.5, 91.0) | (66.3, 99.5) | (68.7, 100.0) | |
| t½,z | 103.3 | 124.7 | 136.1 | 110.3 |
| (85.4, 125.0) | (103.1, 150.9) | (110.8, 167.1) | (91.2, 133.4) | |
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; ESRD, end‐stage renal disease; t½,z, terminal elimination half‐life.
a
The ratio of the various renal impairment groups compared with healthy subjects with normal renal function (ie, renal impairment/normal function × 100).
b
Treatment period 1.