盐酸伐昔洛韦胶囊的人体生物等效性研究

 目的研究2种盐酸伐昔洛韦胶囊的生物等效性。方法24名健康受试者单剂量交叉口服600mg2种盐酸伐昔洛韦胶囊,采用HPLC-UV测定其体内代谢转化物阿昔洛韦的血药浓度。数据经DAS软件处理。结果盐酸伐昔洛韦供试制剂与参比制剂(胶囊)的主要药动学参数如下:AUC_{0→t分别为:(12.985±2.271),(12.306±3.260)mg·h·L^-1;AUC0→∞分别为:(13.416±2.333),(12.748±3.394)mg·h·L^-1;ρmax分别为:(3.897±1.065),(3.592±1.356)mg·L^-1;tmax分别为:(1.354±0.561),(1.479±0.447)h;t1/2分别为:(2.889±0.518),(2.959±0.602)h。对口服供试制剂和参比制剂后的lnAUC0→t,lnAUC0→∞,lnρmax进行方差分析与双单侧t检验,tmax进行秩和检验,结果2者为生物等效制剂(P<0.05)。供试品的相对生物利用度为:(110.4±26.7)%。结论2种盐酸伐昔洛韦胶囊生物等效。}

Bioequivalence of Valaciclovir Capsules in Human

OBJECTIVE To investigate the pharmacokinetics, relative bioavailability and bioequivalence of two different valaciclovir capsules in human beings. METHODS A single oral dose of 600 mg of test and reference valaciclovir capsules was given respectively to 24 healthy male volunteers according to an open randomized crossover design. The acyclovir concentration in plasma was determined by a HPLC-UV method. The data were analysed by DAS. RESULTS The main pharmacokinetic parameters were: AUC_0→t of test and reference preparation were (12.985±2.271) and (12.306±3.260) mg·h·L^-1;AUC_0→∞ were(13.416±2.333) and (12.748±3.394) mg·h·L^-1;ρ_max were (3.897±1.065) and (3.592±1.356)mg·L^-1;t_max were (1.354±0.561) and (1.479±0.447)h; t_1/2 were (2.889± 0.518) and (2.959±0.602) h, respectively. The main pharmacokinetic parameters of two products showed no statistically significant difference according to DAS results. CONCLUSION Both preparations are bioequivalent.