Table 4.
The observed and predicted arithmetic mean AUClast, Cmax, CL values, and their ratios for tegoprazan and M1.
| Parameters | Observed (n = 12) |
Predicted (n = 1000) |
Ratio (Predicted/Observed) |
|---|---|---|---|
| Tegoprazan | |||
| AUC0–24 h (ng × h/mL) |
5611 (3783–7489) |
5145 (2819–8135) |
0.90 (0.85–0.96) |
| Cmax (ng/mL) | 1425 (908–2184) |
1276 (896–1708) |
0.88 (0.80–1.00) |
| CL (L/h) | 17.8 (13.1–24.4) |
21.5 (12.3–35.5) |
1.25 (1.17–1.34) |
| Tmax (h) | 1.0 (0.5–1.0) |
0.55 (0.3–1.6) |
- |
| M1 | |||
| AUC0–48 h (ng × h/mL) | 8334 (6020–10,834) |
7319 (4587–11,151) |
0.88 (0.84–0.94) |
| Cmax (ng/mL) | 397.9 (238.9–575.5) |
395.9 (142.1–1103.3) |
1.01 (0.95–1.08) |
| Tmax (h) | 4.0 (3.0–8.0) |
6.3 (1.2–17.6) |
- |
All parameters are presented as the arithmetic mean (5th–95th percentile), except Tmax, which is presented as the median (minimum–maximum value). The acceptance criteria for Cmax and AUClast ratio were within 30%. AUC: area under the curve from time 0 to the last sampling time point (for tegoprazan and M1, these AUCs were for 0–24 h and 0–48 h, respectively); Cmax, maximum concentration; CL, clearance; Tmax, time of maximum drug concentration