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目的:探析氟康唑胶囊的人体药代动力学及其生物利用度。方法:筛选24例男性健康志愿者,将其分为两组,试验当日早晨取空白血样,两组志志愿者空腹1次口服试验制剂或参比制剂氟康唑胶囊300mg,在固定的时间点抽取血样,并且对血样数据进行统计分析。结果:在药代动力学参数方面,Cmax和AUC0-96T在制剂间及周期间无显著性差异,但个体间差异较大。在生物等效性评价方面,受试药物的相对生物利用度为98.24%～107.54%,AUC0-96R90%可信限在参比制剂的80%～125%之间,Cma(x1-2α)的90%可信限在参比制剂的规定范围内。在药剂间及周期间均无显著性差异(P>0.05),个体间有显著差异(P<0.01)。结论:受试制剂与参比制剂氟康唑胶囊的生物利用度等效,但个体间差异较大。
Objective: To investigate the pharmacokinetics and bioavailability of fluconazole capsules. Methods: Twenty-four male healthy volunteers were selected and divided into two groups. Blood samples were collected on the morning of the test. Two volunteers were given either fasting oral test formulation or reference formulation fluconazole capsule 300mg. At a fixed time point Blood samples were taken and statistical analyzes were performed on the blood sample data. Results: There was no significant difference in the pharmacokinetic parameters between Cmax and AUC0-96T during the formulation and the week, but the differences between the two groups were significant. In bioequivalence assessment, the relative bioavailability of the tested drugs was 98.24% -107.54%, the AUC0-96R90% confidence limit was between 80% and 125% of the reference formulation, and the relative bioavailability of Cma (x1-2α) The 90% confidence limit is within the prescribed limits for the reference formulation. There was no significant difference (P> 0.05) between treatments and weeks, with significant difference between individuals (P <0.01). Conclusion: The bioavailability of the test preparation and the reference formulation fluconazole capsule is equivalent, but there is a big difference between the two groups.