Table 1.
Pharmacokinetic parameters of esomeprazole 40 mg once daily in fed and fasting healthy adult volunteers
| Day 1 | Day 5 | |||||
|---|---|---|---|---|---|---|
| Parameter | Fed | Fasting | Ratio* | Fed | Fasting | Ratio* |
| AUC | ||||||
| n | 35 | 43 | 35 | 43 | 44 | 43 |
| µmol h−1 l−1 | 4.04 (3.2) | 6.71 (4.3) | 0.56 (0.50, 0.64) | 9.47 (3.3) | 12.31 (4.1) | 0.78 (0.74, 0.82) |
| AUC0–t | ||||||
| n | 44 | 44 | NC | 44 | 44 | NC |
| µmol h−1 l−1 | 2.80 (3.2) | 6.66 (4.1) | 9.22 (3.3) | 12.22 (4.1) | ||
| Cmax | ||||||
| n | 44 | 44 | 35 | 44 | 44 | 43 |
| µmol l−1 | 0.88 (1.1) | 3.48 (1.5) | 0.34 (0.28, 0.41) | 2.45 (1.4) | 5.37 (1.4) | 0.47 (0.41, 0.52) |
| tmax, h† | ||||||
| n | 44 | 44 | 44 | 44 | ||
| Median | 4.02 | 2.00 | — | 2.50 | 1.50 | — |
| Range | 0.77–9.00 | 1.00–4.02 | 0.77–8.00 | 0.77–4.50 | ||
| t1/2, h† | ||||||
| n | 37 | 44 | 43 | 44 | ||
| Mean | 1.53 | 1.07 | — | 1.47 | 1.28 | — |
| Range | 0.59–4.10 | 0.55–2.05 | 0.90–4.30 | 0.85–1.73 | ||
Values shown are geometric means (SD) unless otherwise indicated. AUC, Area under the plasma concentration–time curve; AUC0–t, area under the plasma concentration–time curve from time 0 to the time of last quantifiable concentration; CI, confidence interval; Cmax, maximum plasma esomeprazole concentration; tmax, time to peak esomeprazole concentration; t1/2, elimination half-life.
Ratio (90% CI) of fed to fasting calculated for those subjects with profiles from both periods.
Arithmetic mean (range) or median (range).