Table 3.
Statistical Summary of Ertugliflozin Exposure Comparison Between Healthy Japanese and Western Subjects in Cohort A
| Adjusted Geometric Means | |||||
|---|---|---|---|---|---|
| Dose | Parameter | Japanese | Western | Ratio of Adjusted Geometric Means, % | 90%CI for Ratio |
| 1 mg | Cmax, ng/mL | 17.9 | 16.6 | 107.59 | 87.61‐132.11 |
| AUClast, ng • h/mL | 77.6 | 80.9 | 95.94 | 78.76‐116.87 | |
| 5 mg | Cmax, ng/mL | 91.6 | 93.9 | 97.47 | 79.38‐119.69 |
| AUClast, ng • h/mL | 466 | 467 | 99.66 | 81.81, 121.40 | |
| AUCinf, ng • h/mL | 476 | 481 | 98.94 | 81.17‐120.61 | |
| 25 mg | Cmax, ng/mL | 429 | 536 | 80.04 | 65.18‐98.28 |
| AUClast, ng • h/mL | 2365 | 2618 | 90.32 | 74.14‐110.02 | |
| AUCinf, ng • h/mL | 2402 | 2638 | 91.05 | 74.70‐110.99 | |
AUC, area under the plasma concentration–time curve; AUCinf, AUC from time 0 extrapolated to infinite time; AUClast, AUC from time 0 to the time of last measurable concentration; CI, confidence interval; Cmax, maximum observed plasma concentration.
Mixed‐effect model with dose, populations, and interaction term of dose by population as fixed effects, subject within population as random effect.