Table 2. Pharmacokinetic parameters for test and reference formulations of 100 mg tegoprazan tablets (n = 12).
| Variable | Parameters | Test drug (n = 12) | Reference drug (n = 12) | GMR (90% CI) |
|---|---|---|---|---|
| Tegoprazan | Tmax (h) | 0.83 ± 0.25 | 0.71 ± 0.26 | - |
| Cmax (μg/L) | 1,434.50 ± 570.82 | 1,415.92 ± 326.78 | 0.98 (0.86–1.12) | |
| AUClast (h*μg /L) | 5,720.00 ± 1,417.86 | 5,502.99 ± 1,070.62 | 1.03 (0.94–1.13) | |
| AUCinf (h*μg /L) | 5,998.13 ± 1,379.16 | 5,761.39 ± 1,025.87 | ||
| t1/2 (h) | 4.41 ± 1.07 | 4.08 ± 0.85 | ||
| CL/F (L/h) | 17.58 ± 4.48 | 17.92 ± 3.49 | ||
| Vd/F (L) | 107.90 ± 22.58 | 103.31 ± 19.25 | ||
| M1 | Tmax (h) | 4.33 ± 1.15 | 4.25 ± 1.22 | |
| Cmax (μ/L) | 396.67 ± 108.67 | 399.17 ± 109.41 | 0.99 (0.89–1.11) | |
| AUClast (h*μ/L) | 8,328.93 ± 1,351.80 | 8,338.81 ± 1,799.07 | 1.01 (0.93–1.09) | |
| AUCinf (h*μ/L) | 9,125.80 ± 1,660.49 | 9,639.38 ± 2,418.67 | ||
| t1/2 (h) | 14.26 ± 5.77 | 16.89 ± 5.48 | ||
| Metabolic ratio | 1.52 ± 0.39 | 1.44 ± 0.31 |