伏立康唑胶囊人体药动学及相对生物利用度研究

梅源; 郑国钢; 藏恒昌

伏立康唑胶囊人体药动学及相对生物利用度研究

Study on Pharmacokinetics and Relative Bioavailability of Voriconazole Capsules in Healthy Volunteers

摘要

摘要: 目的研究健康受试者口服伏立康唑胶囊的药动学和相对生物利用度。方法 20名健康受试者随机服用伏立康唑受试胶囊剂和参比片剂各100 mg，用HPLC-MS/MS测定血浆中伏立康唑的浓度。结果主要药动学参数，伏立康唑受试制剂与参比制剂的T_max分别为(0.75±0.15)和(0.84±0.25)h，C_max分别为(605.4±136.6)和(595.2±134.7)ng·mL^-1；t_1/2分别为(4.91±1.44)和(5.06±2.06)h，AUC_0-15分别为(1737.6±325.1)和(1750.6±352.8)ng·h·mL^-1。受试制剂与参比制剂的AUC_0-15和C_max经双单侧t检验，T_max经非参数检验，差异均无统计学意义。结论统计学结果表明，2种制剂生物等效。

Abstract: OBJECTIVE To study the pharmacokinetics and relative bioavailability of voriconazole capsules. METHODS A single oral dose of 100 mg voriconazole test capsules and reference tablets was given to 20 healthy male volunteers according to a randomized cross over design. Plasma concentration of voriconazole was determined by HPLC-MS/MS. RESULTS The main pharmacokinetic parameters of test capsules and reference tablets were as follows: T_max(0.75±0.15) and (0.84±0.25)h, C_max (605.4±136.6) and (595.2±134.7)ng·mL^-1, t_1/2 (4.91±1.44) and (5.06±2.06)h, AUC_0-15 (1737.6±325.1) and (1750.6±352.8)ng·h·mL^-1, respectively. Through the one or two-side test for AUC_0-15 and C_max, and T_max with the Wilcoxon test, no significant difference was found. CONCLUSION The two formulations are bioequivalent.

HTML全文

参考文献(1)

施引文献

资源附件(0)