Table 2.
Mean pharmacokinetic parameters of ilaprazole and esomeprazole in healthy subjects and patients with duodenal ulcers (mean ± standard deviation)
| Parameters | Study A | Study B | Study C | |||
|---|---|---|---|---|---|---|
| Ilaprazole | Esomeprazole | Ilaprazole | Ilaprazole | Ilaprazole | Esomeprazole | |
| (30 mg, day 1) | (80 mg, day 1) | (20 mg, day 1) | (10 mg, day 3) | (20 mg, day 1) | (40 mg, day 1)b | |
| (n = 10) | (n = 6) | (n = 12) | (n = 12) | (n = 10) | (n = 10) | |
| t1/2 (h) | 3.0 ± 0.5 | 1.5 ± 0.2 | 3.3 ± 0.6 | 3.1 ± 0.7 | 3.1 ± 0.6 | 1.6 ± 0.4 |
| tmax(h)a | 0.75 (0.75–0.75) | 0.75 (0.75–0.76) | 0.75 (0.75–0.83) | 0.75 (0.75–0.75) | 0.75 (0.75–0.78) | 0.75 (0.75–0.77) |
| Cmax (ng mL−1) | 3101.4 ± 468.7 | 5680.2 ± 524.9 | 1871.3 ± 242.0 | 876.9 ± 84.4 | 1540.3 ± 241.0 | 3040.1 ± 875.1 |
| AUC0–t (μg mL h−1) | 10.3 ± 2.0 | 13.5 ± 1.4 | 7.4 ± 2.1 | 3.5 ± 0.8 | 4.7 ± 0.9 | 7.4 ± 3.9 |
| AUC0–∞ (μg mL h−1) | 10.5 ± 2.1 | 13.6 ± 1.6 | 7.4 ± 2.2 | 3.5 ± 0.9 | 4.9 ± 1.1 | 7.5 ± 3.8 |
| V (L) | 11.5 ± 1.4 | 12.5 ± 1.6 | 12.9 ± 2.1 | 11.3 ± 1.2 | 17.6 ± 2.7 | 14.0 ± 3.4 |
| CL (L h−1) | 3.0 ± 0.6 | 5.9 ± 0.7 | 2.9 ± 0.8 | 3.1 ± 0.7 | 4.1 ± 0.9 | 6.7 ± 2.6 |
Data are represented as mean ± standard deviation.
a
For t max, median (range);
b
For esomeprazole cohort in study C, the given dose was 40 mg twice daily and the last time point was 12 h (i.e. AUC0–t = AUC0–12).