TABLE 4.
FEP and TAZ urine PK parameters
| Drug, parameter (units), and statistic | Mild |
Moderate |
Severe |
ESRD on HD control (n = 6) | |||
|---|---|---|---|---|---|---|---|
| Impairment (n = 6) | Control (n = 6) | Impairment (n = 5) | Control (n = 6) | Impairment (n = 6) | Control (n = 6) | ||
| FEP | |||||||
| Ae0–48 (mg) | |||||||
| Mean | 1,981.1 | 2,030.4 | 1,562.8 | 1,914.8 | 438.7 | 1,950.2 | 2,158.1 |
| SD | 563.0 | 330.4 | 563.3 | 308.3 | 102.6 | 276.1 | 374.7 |
| CLR (ml/min) | |||||||
| Mean | 79.2 | 105.9 | 39.1 | 104.5 | 9.5 | 93.5 | 111.2 |
| SD | 23.5 | 22.1 | 10.6 | 14.6 | 3.2 | 10.8 | 26.5 |
| TAZ | |||||||
| Ae0–48 (mg) | |||||||
| Mean | 1,907.2 | 1,791.0 | 1,365.1 | 1,776.6 | 296.1 | 1,842.9 | 2,088.2 |
| SD | 639.3 | 291.0 | 412.9 | 269.3 | 53.2 | 174.8 | 241.4 |
| CLR (ml/min) | |||||||
| Mean | 249.7 | 275.9 | 109.8 | 308.0 | 23.1 | 267.6 | 339.7 |
| SD | 96.6 | 57.0 | 29.0 | 60.5 | 8.9 | 33.5 | 88.6 |