泛昔洛韦分散片在人体内的生物等效性

Bioequivalence of Famciclovir dispersible tablets in human body

目的研究泛昔洛韦分散片和泛昔洛韦片在人体内的生物等效性。方法采用双制剂双周期自身交叉对照法,将20名健康男性受试者随机分为两组,口服泛昔洛韦分散片受试制剂及参比制剂各0.5 g。血浆中的泛昔洛韦浓度用HPLC法测定,用DAS软件计算药物动力学参数,并对其进行生物等效性评价。结果泛昔洛韦分散片受试制剂与参比制剂的AUC0→Tn分别为13.80±2.73、13.65±2.42μg.h.ml-1;AUC0→∞分别为14.62±2.73、14.35±2.28μg.h.ml-1;Cmax分别为3.42±0.67、3.45±0.67μg.ml-1;Tmax分别为1.11±0.31、1.05±0.25 h。受试制剂的相对生物利用度为101.12%±8.56%。结论口服泛昔洛韦受试制剂和参比制剂相比,AUC、Cmax符合生物等效性要求,Tmax比较无显著性差异,两者生物等效。

OBJECTIVE To study the bioequivalence of Famciclovir dispersible tablets and Farnciclovir tablets in human body.METHODS According to a paired, cross - over design, 20 healthy male volunteers were randomly divided into two groups. A single oral dose of 0.5 g famciclovir either the test dispersant or its reference was given to them. The plasma concentration of famciclovir was determined by HPLC. The pharmacokinetic parameters were calculated by DAS program and the bioequivalence of the two tablets was evaluated. RESULTS AUCo→Tn, of test and reference were 13.80 ± 2.73,13.65 ±2.42 μg·h·ml^-1 ; AUCo→∞ were 4.62 ＋ 2.73, 14.35 ＋ 2.28μg·h·ml^-1 ; Cmax were 3.42 ± 0.67,3.45 ± 0.67 μg·h·ml^-1; Tmax were 1.11 ±0.31,1.05 ± 0.25 h, respectively. The bioavailability of the test formation was 101.12 % ± 8.56%. CONCLUSION The test famciclovir dispersible tablets were bioequivalent to the reference preparation.