医药导报2013，Vol.32Issue(3)：306-309,4.DOI:10.3870/yydb.2013.03.010
非洛地平缓释片在健康志愿者体内的生物等效性研究
Bioequivalence of Felodipine Sustained-release Tablets in Healthy Volunteers
摘要
Abstract
Objective To set up a method for determination of felodipine in human plasma by HPLC-MS/MS and study the relative bioavailability and bioequivalence of felodipine sustained - release tablets. Methods Twenty healthy male volunteers were randomized to receive a single dose of tested felodipine sustained-release tablet or the reference tablet by a two-way crossover design. Plasma concentration of felodipine was determined by HPLC-MS/MS and the bioequivalence between two formulations were evaluated by DAS2. 0 program. Results The pharmacokinetic parameters of the tested and the reference felodipine tablet were expressed as follows: Cmax was (2. 15±0. 63) ng · mL-1 and (2. 29±0. 63) ng · mL-1 , tmax was (6. 33± 1.57) h and (6.68±1.32) h, t1/2 was (18.22±2.75) h and (19.04±2.27) h, AUC0-48 were (58. 11±5. 15) ng · mL-1 · h and (61. 13±6. 31) ng · mL-1· h. The relative bioavailability F was (95.06±8.42) %. Conclusion The two felodipine sustained-release tablets are bioequivalent.关键词
非洛地平缓释片/高效液相色谱-质谱串联法/生物等效性Key words
Felodipine sustained-release tablet/ HPLC-MS/MS/ Bioequivalence分类
医药卫生引用本文复制引用
刘异,裘琳,饶子超,刘东..非洛地平缓释片在健康志愿者体内的生物等效性研究[J].医药导报,2013,32(3):306-309,4.
