Table 3.
Geometric Mean Ratio and Its 90% CI of Main Pharmacokinetic Parameters of Imrecoxib (M0), M1 and M2
| Analyze | Pharmacokinetic | Geometric Mean | Geometric Mean Ratio (%) | ||
|---|---|---|---|---|---|
| Group A (N=10) | Group B (N=9) | B/A | 90% CI | ||
| M0 | Cmax (ng/mL) | 10.8 | 15.0 | 139 | (60.9, 317) |
| AUC0-t (h*ng/mL) | 137 | 183 | 134 | (67.4, 265) | |
| AUC0-∞ (h*ng/m) | 148 | 193 | 130 | (67.5, 250) | |
| M1 | Cmax (ng/mL) | 34.0 | 41.3 | 121 | (87.5, 169) |
| AUC0-t (h*ng/mL) | 358 | 406 | 113 | (87.9, 146) | |
| AUC0-∞ (h*ng/m) | 380 | 421 | 111 | (85.8, 144) | |
| M2 | Cmax (ng/mL) | 122 | 143 | 117 | (89.6, 153) |
| AUC0-t (h*ng/mL) | 1130 | 1440 | 127 | (93.2, 174) | |
| AUC0-∞ (h*ng/m) | 1230 | 1580 | 128 | (91.3, 179) | |
Notes: Group A: non-elderly group. Group B: elderly group. Cmax and AUC between the two groups are considered to be equivalent if the 90% CIs of geometric mean ratios of Cmax and AUC are located within 80–125%.
Abbreviations: Cmax, peak concentration; AUC0-t, plasma area under concentration–time curve from time 0 to the last measurable concentration; AUC0-∞, plasma area under concentration–time curve from time 0 to infinity; CIs, confidence intervals.