Statistical analysis of pharmacokinetic parameters of RE and its metabolites between renal function groups
Values are the point estimate (90% confidence interval) of the geometric least-squares mean ratio PK parameter, renal impairment versus matched normal.
| PK Parameter | Mild Renal Impairment/Matched Normal | Moderate Renal Impairment/Matched Normal |
|---|---|---|
| Remogliflozin etabonate | ||
| AUC(0-t) | 1.20 (0.749, 1.92) | 1.18 (0.677, 2.04) |
| Cmax | 1.56 (0.841, 2.90) | 0.753 (0.365, 1.55) |
| t1/2 | 1.11 (0.678, 1.83) | 1.76 (0.990, 3.12) |
| Remogliflozin | ||
| AUC0-∞ | 1.08 (0.798, 1.47) | 1.14 (0.800, 1.64) |
| Cmax | 1.35 (0.836, 2.18) | 0.933 (0.533, 1.63) |
| t1/2 | 1.09 (0.998, 1.20) | 1.17 (1.05, 1.31) |
| AUC ratio, m/p | 0.903 (0.622, 1.31) | 0.974 (0.630, 1.51) |
| % Dose recovered | 0.687 (0.501, 0.941) | 0.408 (0.284, 0.586) |
| CLr | 0.633 (0.473, 0.847) | 0.357 (0.255, 0.499) |
| AUC0-∞,u | 1.08 (0.790, 1.47) | 1.12 (0.781, 1.62) |
| CLr,u | 0.630 (0.470, 0.845) | 0.350 (0.250, 0.491) |
| GSK279782 | ||
| AUC0-∞ | 1.51 (0.930, 2.45) | 1.34 (0.763, 2.37) |
| Cmax | 1.69 (0.959, 2.99) | 1.02 (0.524, 1.99) |
| t1/2 | 1.09 (0.955, 1.25) | 1.15 (0.980, 1.34) |
| AUC ratio, m/p | 1.39 (0.834, 2.32) | 1.18 (0.645, 2.14) |
| % Dose recovered | 0.734 (0.424, 1.27) | 0.337 (0.179, 0.634) |
| CLr | 0.528 (0.357, 0.781) | 0.252 (0.160, 0.395) |
| AUC0-∞,u | 1.55 (0.962, 2.50) | 1.35 (0.771, 2.36) |
| CLr,u | 0.541 (0.370, 0.792) | 0.253 (0.163, 0.391) |
| GSK333081 | ||
| AUC0-∞ | 1.29 (0.872, 1.92) | 1.68 (1.06, 2.67) |
| Cmax | 1.32 (0.812, 2.16) | 1.21 (0.681, 2.14) |
| t1/2 | 1.20 (1.01, 1.43) | 1.28 (1.04, 1.57) |
AUC(0-t), area under curve fro 0 to last measurable concentration; AUC0-∞,u, area under curve from 0 to infinity corrected for unbound fraction; CLr, renal clearance; CLr,u, renal clearance corrected for unbound fraction.