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To study the pharmacokinetic profile of oseltamivir phosphate dry syrup in Chinese healthy subjects and to evaluate the bioequivalence and safety of the test formulation (T) and the reference formulation (R) under fasting and fed conditions.
In a randomized, open, two-agent, two-sequence, two-cycle, double-crossover trial design, 36 healthy subjects were enrolled in the fasting and fed groups, respectively, who received a single oral dose of 2.5 g of oseltamivir phosphate dry syrup of either the T or R. The blood concentrations of oseltamivir were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS), and the pharmacokinetic parameters were calculated by using the WinNonlin (8.2) software and evaluated for bioequivalence and safety.
Under fasting conditions, the Cmax of oseltamivir of the T and R were (64.40±17.50) and (64.10±20.90) ng·mL-1, AUC0-t were (142.76±43.64) and (151.60±35.10) h·ng·mL-1, AUC0-∞ were (147.67±37.60) and (153.05±35.30) h·ng·mL-1, respectively. Under fed conditions, the Cmax of oseltamivir of the T and R were (47.70±18.30) and (46.90±17.20) ng·mL-1, AUC0-t were (170.52±26.28) and (168.70±24.51) h·ng·mL-1, AUC0-∞ were (173.08±26.50) and (171.30±24.59) h·ng·mL-1, respectively. The 90% confidence intervals for the geometric mean ratios of Cmax, AUC0-t and AUC0-∞ for the T and R fell in the range of 80.00% to 125.00% for both the fasting and fed groups. Adverse drug reaction rates were 27.78% and 44.44% in the fasting and fed groups, respectively.
Two kinds of oseltamivir phosphate dry syrups were bioequivalent and had favorable safety profiles in Chinese healthy subjects in both fasted and fed states.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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