TABLE 6.
PK analysis of time profiles for CKD patients.
| PK parameter | Data type | Healthy | CKD | ||
|---|---|---|---|---|---|
| Mild | Moderate | Severe | |||
| AUC [μg/mL*h] | Predicted | 1,037 | 1,454.63 | 2,011.93 | 2,211.58 |
| Observed | 894.77 | 1,558.10 | 1,970.87 | 2,025.89 | |
| Fold error | 1.16 | 1.07 | 1.02 | 1.09 | |
| T½ [h] | Predicted | 7.67 | 9.40 | 12.88 | 13.08 |
| Observed | 8.96 | 14.69 | 15.30 | 15.42 | |
| Fold error | 1.17 | 1.56 | 1.19 | 1.18 | |
| Clearance [mL/min] | Predicted | 16.10 | 11.45 | 8.30 | 7.54 |
| Observed | 20.05 ± 3.15 | 11.75 ± 4.20 | 8.82 ± 1.62 | 10.05 ± 2.95 | |
| Fold error | 1.25 | 1.03 | 1.06 | 1.33 | |