Table 3.
Pharmacokinetic endpoints for sodium N-(8-[2-hydroxybenzoyl] amino) caprylate (SNAC) after the tenth dosing
| Parameters | Renal function group (full analysis set) | ||||
|---|---|---|---|---|---|
| Normal (n = 24) | Mild (n = 12) | Moderate (n = 12) | Severe (n = 12) | ESRD (n = 11) | |
| AUC24,Day10 (nmol·h/L) | 1028.8 (29.2) | 1311.6 (31.5) | 1335.9 (34.6) | 1522.8 (31.8) | 1471.4 (27.0) |
| Cmax,Day10 (nmol/L) | 971.4 (89.4) | 1086.5 (99.0) | 734.7 (70.4) | 1074.4 (95.0) | 936.3 (88.5) |
| tmax,Day10 (h) | 0.75 (0.33, 3.00) | 0.58 (0.33, 2.50) | 0.67 (0.33, 6.00) | 0.67 (0.17, 1.00) | 0.83 (0.17, 5.00) |
| CLR (L/h) | 0.06 (104.33) | 0.08 (87.88) | 0.09 (92.63) | 0.04 (98.22) | 0.01 (508.51) |
Data are geometric means (coefficient of variation) except for tmax,Day10 where median (minimum, maximum) values are presented
AUC24,Day10 area under the plasma concentration–time curve from time zero to 24 h after the tenth dose, CLR renal clearance, Cmax,Day10 maximum plasma concentration 0–24 h after the tenth dose, ESRD end-stage renal disease, tmax,Day10 time to reach Cmax,Day10, t½ terminal half-life