Table 3.
Mean pharmacodynamics parameters of ilaprazole and esomeprazole according to dose regimens
| Study A | Study Bb | |||||||
|---|---|---|---|---|---|---|---|---|
| Ilaprazole 30 mg (n = 10) | Esomeprazole 80 mg (n = 6) | Day 1 (20 mg) | Day 2(10 mg) | |||||
| Baseline | Day 1 | Baseline | Day 1 | Baseline | (n = 12) | (n = 12) | ||
| Mean 24‐h pH | 1.8 ± 0.3 | 6.2 ± 0.6 | 1.8 ± 0.4 | 5.6 ± 0.5 | 1.8 ± 1.0‡ | 6.1 ± 0.9 | 7.2 ± 0.3 | |
| pH > 4 (%) | 6.9 ± 5.1 | 85.6 ± 9.0 | 7.9 ± 6.8 | 69.2 ± 8.2 | 12.3 ± 8.1 | 80.2 ± 13.2 | 98.9 ± 2.2 | |
| pH > 5 (%) | 3.8 ± 3.2 | 79.6 ± 12.0 | 4.6 ± 4.3 | 62.8 ± 7.3 | 10.3 ± 7.9 | 78.6 ± 16.2 | 96.1 ± 4.8 | |
| pH > 6 (%) | 1.7 ± 1.6 | 65.6 ± 12.3 | 1.4 ± 1.3 | 51.7 ± 8.3 | 8.9 ± 6.9 | 69.1 ± 17.0 | 88.6 ± 11.1 | |
| First time to pH > 6 (h)a | 0.8 (0.5–1.9) | 1.1 (0.5–1.8) | 3.1 (0.3–4.5) | |||||
| Mean nocturnal pH | 1.7 ± 0.4 | 5.9 ± 0.7 | 1.7 ± 0.6 | 4.2 ± 0.6 | 1.6 ± 1.1 | 6.3 ± 1.3 | ||
| Night‐time of pH < 4 (h) | 1.9 (0.0–4.4) | 6.0 (3.3–8.4) | ||||||
| Study C | ||||||||
|---|---|---|---|---|---|---|---|---|
| Ilaprazole (n = 10) | Esomeprazole (n = 10) | |||||||
| Baseline | Day 1 (20 mg) | Day 3 (10 mg) | Day 4 (10 mg) | Baseline | Day 1(40 mg) | Day 3 (40 mg) | Day 4(40 mg) | |
| Mean 24‐h pH | 2.7 ± 1.3 | 7.0 ± 1.1 | 7.1 ± 1.5 | 5.1 ± 1.2 | 2.2 ± 0.7 | 7.1 ± 0.6 | 7.3 ± 0.3 | 6.0 ± 0.8 |
| pH > 4 (%) | 22.7 ± 23.1 | 89.3 ± 11.3 | 94.4 ± 15.5 | 59.6 ± 20.2 | 12.6 ± 11.3 | 92.1 ± 5.1 | 99.8 ± 0.2 | 75.5 ± 14.7 |
| pH > 5 (%) | 18.8 ± 19.43 | 84.7 ± 17.3 | 92.0 ± 18.9 | 51.2 ± 19.7 | 7.8 ± 6.8 | 88.7 ± 7.7 | 99.3 ± 0.8 | 68.4 ± 15.9 |
| pH > 6 (%) | 14.3 ± 14.9 | 79.5 ± 24.8 | 86.8 ± 22.4 | 41.9 ± 21.3 | 4.5 ± 3.5 | 82.2 ± 12.1 | 91.1 ± 5.3 | 57.0 ± 14.2 |
| First time to pH > 6 (h)a | 2.5(1.4–4.3) | 2.7(0.2–4.1) | ||||||
| Mean nocturnal pH | 2.8 ± 1.5 | 7.4 ± 1.5 | 7.0 ± 1.7 | 4.9 ± 1.2 | 2.0 ± 0.7 | 7.5 ± 0.7 | 7.3 ± 0.3 | 5.6 ± 1.5 |
Data are represented as mean ± standard deviation.
a
For time to first reach pH > 6 and nocturnal pH < 4 (h), median (range).
b
For study B, the pH value was monitored for 12 h on day −1 (baseline) and day 3.