Table 4.
Pharmacokinetic parameters | Reference formulation (mean ± SD) | Test formulation (mean ± SD) | 90% Confidence limit (%) |
---|---|---|---|
T max (h) | 3.65 ± 1.14 | 3.85 ± 1.04 | |
C max (ng/ml) | 34.3 ± 9.5 | 44.1 ± 27.6 | 103.8–142.3 |
AUC0–60d (ng h/ml) | 1679 ± 385 | 1789 ± 383 | 100–114.2 |
AUC0–∞ (ng h/ml) | 1819 ± 417 | 1950 ± 435 | 100–115.5 |
t 1/2 (h) | 272 ± 76 | 298 ± 105 |
Reference formulation: Shanghai Zhongxi Pharmaceutical Co., Ltd., Shanghai, China
Test formulation: Jiangsu Shenhua Pharmaceutical Co., Ltd., Jiangsu, China