泛昔洛韦分散片人体生物等效性研究

Bioequivalence of Famciclovir Dispersible Tablets in Human

18名健康男性志愿者随机交叉口服单剂量250mg泛昔洛韦分散片和薄膜衣片,考察两种制剂的生物等效性。采用HPLC法测定血浆中泛昔洛韦的活性代谢物喷昔洛韦的浓度。结果表明,两种制剂的AUC0→8h和AUC0→∞无显著性差异,分散片的Cmax较高、Tmax较小。泛昔洛韦分散片的相对生物利用度为(104.7±12.9)%,双单侧t检验结果表明两制剂具有生物等效性。

The bioequivalence of famciclovir dispersible tablets and film-coated tablets was investigated with a randomized crossover design at a single oral dose of 250mg in 18 healthy male volunteers. The concentration of penciclovir, the active metabolite in human plasma after administration of famciclovir, was determined by a HPLC method. The results showed that AUC0→8h and AUC0→∞of the two preparations had no significant difference, Cmax of the dispersible tablets increased and Tmax decreased. The relative bioavailability of dispersible tablets was （104.7±12.9） %. The results of two one-side t test showed that the two preparations were bioequivalent.