Table 3.
Parameter | Dose (mg) | N a | Geometric means | Statistics | ||
---|---|---|---|---|---|---|
On dialysis (test, T) | Non-dialysis (reference, R) | GMR (T/R) | 90% Confidence limit | |||
AUC tau (ng•h/mL) | 30 | 11/14 | 86.46 | 94.14 | 91.85 | 81.02, 104.12 |
60 | 10/10 | 188.59 | 159.84 | 117.99 | 103.56, 134.43 | |
120 | 10/10 | 418.26 | 442.56 | 94.51 | 83.46, 107.03 | |
180 | 13/9 | 567.05 | 599.15 | 94.64 | 82.95, 107.99 | |
C max (ng/mL) | All doses | 15/14 | 31.04 | 31.39 | 98.90 | 89.73, 109.01 |
aNumber of patients on dialysis/non-dialysis days.
Abbreviations: AUC tau area under the plasma concentration-time curve over the dosing interval, CI confidence interval, C max maximum observed plasma concentration, h hour, GMR geometric mean ratio.