Pharmacokinetic parameter | Reference (mean ± SD) | Test (mean ± SD) | Geometric mean ratio of T/R (90% CI)a | P value |
---|---|---|---|---|
Cmaxa, μg mL−1 | 0.6577 ± 0.01 | 0.7792 ± 0.01 | 118.50% (115.21, 121.78)b | 0.0002 |
Tmax, h | 6.1 ± 0.36 (5.8–6.5) | 4.0 ± 0.46 (3.5–4.4) | – | 0.9853 |
T1/2, h | 21.5261 ± 0.57 | 20.3629 ± 0.20 | – | 0.7709 |
AUC0-ta , μg h mL−1 | 17.3070 ± 0.29 | 19.7973 ± 1.06 | 114.57 (106.66, 122.47)b | 0.0146 |
AUC0-∞a , μg h mL−1 | 25.2047 ± 0.67 | 25.1649 ± 0.89 | 100.09 (91.76, 108.41)b | 0.9493 |
MRT, h | 31.2453 ± 0.69 | 29.3837 ± 0.55 | – | 0.2436 |
Ke | 0.0320 ± 0.01 | 0.0340 ± 0.01 | – | 0.4826 |