Table 3.
Exenatide pharmacokinetic parameters by renal group in the single study
| Geometric mean (CV%) | |||||
|---|---|---|---|---|---|
| Parameter (units) | Healthy | Mild RI | Moderate RI * | ESRD | |
| n | 8 | 8 | 5 | 1 | 8 |
| Dose (µg) | 10 | 10 | 5 | 10 | 5 |
| Cmax (pg ml−1) | 821 (61.0) | 470 (24.6) | 202 (19.9) | 353 | 601 (69.4) |
| AUC0–∞ (pg h ml−1) | 2930 (31.4) | 2080 (17.4) | 1150 (15.2) | 2090 | 5380 (42.2) |
| CLp/F (l h−1) | 3.4 (31.4) | 4.8 (17.4) | 4.4 (14.2) | 0.9 (42.2) | |
| Vz/F (l) | 7.1 (40.2) | 14.7 (21.9) | 20.2 (45.1) | 8 (43.9) | |
| t1/2 (h)† | 1.5 (0.9–2.0) | 2.1 (1.6–3.4) | 3.2 (1.8–7.0) | 6 (4.3–7.6) | |
| Tmax (h)† | 2.0 (1.0–3.0) | 2.0 (0.5–3.0) | 2.50 (1.0–3.0) | 2.0 (1.0–4.0) | |
*
One subject in the 10-µg group was excluded as an outlier from all statistical evaluations.
†
t1/2and Tmaxrepresented as mean (range) and median (range), respectively.