【摘要】 目的:评价盐酸特比萘芬片人体生物等效性。方法:18例健康志愿者随机交叉口服单剂量(0.25 g)盐酸特比萘芬片试验制剂与参比制剂,采用LC-MS/MS法测定血浆中特比萘芬的血药浓度。结果:试验制剂与参比制剂的主要药动学参数Cmax分别为(941.6±196.5)和(917.1±264.8)μg.L-1,Tmax分别为(1.38±0.39)和(1.38±0.61)h,AUC0~72 h分别为(4696.4±1192.8)和(4 596.9±1189.8)μg.h.L-1,AUC0~∞分别为(4838.7±1188.1)和(4755.9±1183.2)μg.h.L-1。试验制剂对参比制剂的相对生物利用度F(以AUC0~72 h作为评价依据)为(98±9)%。结论:盐酸特比萘芬片试验制剂与参比制剂生物等效。更多还原

【Abstract】 Objective:To evaluate the relative bioavailability of terbinafine hydrochloride tablets.Methods:The plasma concentrations of terbinafine from 18 healthy male volunteers,who received a single crossover dose of test and reference terbinafine 0.25 g,were measured by LC-MS/MS.Results:The pharmacokinetic profiles of test and reference terbinafine were Cmax,(941.6±196.5) vs(917.1±264.8) μg·L-1;Tmax,(1.38±0.39) vs(1.38±0.61)h;AUC0~72 h,(4 696.4±1 192.8) vs (4 596.9±1 189.8) μg·h·L-1;AUC0~∞,(4 838.7±1 188.1) vs(4 755.9±1 183.2)μg·h·L-1,respectively.The relative bioavailability of the test terbinafine was(98±9)%.Conclusion:The test terbinafine was bioequivalent to the refrence terbinafine.更多还原