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Tmax分别为(0.75±0.15)和(0.84±0.25)h,Cmax分别为(605.4±136.6)和(595.2±134.7)ng.mL 1;t1/2分别为(4.91±1.44)和(5.06±2.06)h,AUC0-15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AUC0-15和Cmax经双单侧t检验,Tmax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。
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： Tmax（0.75±0.15） and （0.84±0.25）h, Cmax （605.4±136.6） and （595.2± 134.7）ng mL-1, t1/2 （4.91± 1.44） and （5.06±2.06）h, AUC0.15 （1737.6±325.1） and （1750.6±352.8）ng-h-mL-1, respectively. Through the one or two-side test for AUC0_15 and Cmax, and Tmax with the Wilcoxon test, no significant difference was found. CONCLUSION The two formulations are bioequivalent.
出处
《中国现代应用药学》
CAS
CSCD
2013年第5期499-502,共4页
Chinese Journal of Modern Applied Pharmacy
