Table 2.
Comparison of plasma sitagliptin AUC0–∞ and Cmax between fasted, healthy, young Japanese males in the present study (Table 1) and historical data from fasted, healthy, young non-Japanese males [6]
Dose (mg) | n | GMR for AUC0–∞(90% CI) | GMR for Cmax(90% CI) |
---|---|---|---|
5 | 6 | 1.14 (1.02, 1.27) | 1.36 (1.11, 1.67) |
12.5 | 6 | 1.02 (0.91, 1.14) | 1.14 (0.92, 1.40) |
25 | 6 | 1.05 (0.94, 1.17) | 1.11 (0.90, 1.36) |
50 | 6 | 0.91 (0.82, 1.02) | 0.95 (0.77, 1.18) |
100 | 6 | 1.11 (1.00, 1.23) | 1.30 (1.07, 1.57) |
200 | 6 | 1.06 (0.97, 1.17) | 1.02 (0.85, 1.21) |
400 | 6 | 0.87 (0.78, 0.97) | 0.85 (0.69, 1.03) |
AUC0–∞, post-dose area under the curve for plasma sitagliptin concentration over time extrapolated to infinity; CI, confidence interval; Cmax, maximum plasma concentration of sitagliptin; GMR, ratio of geometric least-square means (Japanese/non-Japanese).