Table 6 The results of Cmax, AUC0 − t and AUC0−∞ bidirectional one-sided T-test and [1–2α] CI method (BES, N = 12).
Parameter | t-value | P-value | Geometric mean and ratio (N = 12) | Individual variability %CV of subjects | 90% CI | ||||
|---|---|---|---|---|---|---|---|---|---|
Compared to the lower limit tL | Compared to the high limit tH | Compared to the lower limit PL | Compared to the high limit PH | Sample R | Sample S | (S/R) % | |||
Cmax (np/ml) | 3.33 | -4.35 | 0.0038 | 0.0007 | 1.42 | 1.38 | 97.09 | 14.30 | 87.39%~107.87% |
AUC0 − t (ng∙h/ml) | 0.72 | -12.07 | 0.2454 | 0.0000 | 12.32 | 10.11 | 82.02 | 8.56 | 76.99%~87.38% |
AUC0−∞ (ng∙h/ml) | 0.75 | -12.28 | 0.2340 | 0.0000 | 12.47 | 10.24 | 82.09 | 8.40 | 77.15%~87.35% |
