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To explore the pharmacokinetic (PK) characteristics of desloratadine tablets and reference drugs in healthy subjects, and evaluate their bioequivalence and safety.
The random, open, two-period, cross-over pharmacokinetic study method was adopted, each subject received a single oral dose of desloratadine tablets test drug(T) or reference drug(R) for 5 mg. The concentrations of desloratadine and 3-hydroxy desloratadine in plasma were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS); and the PK parameters were calculated by WinNonlin 8.1 software to evaluate the bioequivalence.
The main PK parameters of T and R of desloratadine were as follows: the fasting condition Cmax were respectively (3 809.82±1 016.54) and (3 642.36±777.07) pg·mL-1; AUC0-120h were respectively (5.75×104±5.03×104) and (5.51×104±4.00×104) pg·h·mL-1; AUC0-∞ were respectively (6.85×104±1.03×104) and (6.37×104±7.92×104) pg·h·mL-1. The fed condition Cmax were respectively (4 398.98±1 191.22) and (4 744.40±1 511.97) pg·mL-1; AUC0-120 h were respectively(5.25×104±1.82×104) and (5.55×104±1.98×104) pg·h·mL-1; AUC0-∞ were respectively(5.37×104±1.86×104) and (5.68×104±2.04×104) pg·h·mL-1. The 90% confidence interval of Cmax, AUC0-t and AUC0-∞ of desloratadine were all within 80.00%~125.00%.
There was no significant difference in the main PK parameters between T and R under fasting or high-fat postprandial conditions, and desloratadine tablets were bioequivalent, safe and well tolerated.
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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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