中国临床药理学与治疗学2018，Vol.23Issue(10)：1141-1146,6.DOI:10.12092/j.issn.1009-2501.2018.10.009
高变异药物醋酸阿比特龙片人体生物等效性评价
Bioequivalence of high variation drug abiraterone acetate tablets in healthy subjects
摘要
Abstract
AIM: To evaluate the bioequiva-lence of the experimental preparation and reference preparation of the high-variation drug abiraterone ac-etate tablets administered once orally in the healthy Chinese volunteers after taking fatty food. METH-ODS: It was a randomized, open-label, double-se-quence, four-period, repeated cross-test and 32 healthy volunteers were given a single oral 250 mg dose of test or reference abiraterone acetate tablets with a high-fat meal. The blood concentrations of abiraterone in plasma were determined by LC-MS/MS. The major pharmacokinetic parameters were calculated with the aid of WinNonlin 7 and the bio-equivalence was evaluated. RESULTS: The abi-raterone's major pharmacokinetic parameters of test and reference were as follows: Cmaxwere(238. 0 ± 108. 6) and(220. 1 ± 96. 9) ng/mL; Tmaxwere 2. 0 (1. 0-4. 0) and 2. 0 (1. 0-5. 0) h; t1/2were (13. 1 ± 2. 6) and (13. 0 ± 2. 9) h; AUC0-twere (615. 2 ± 226. 3 ) and ( 589. 4 ± 210. 1 ) h·ng·mL-1, AUC0-∞were ( 618. 7 ± 227. 7 ) and ( 592. 8 ± 211. 6) h·ng·mL-1, respectively. The 90% con-fidence interval, the geometric mean ratio(T/R)of the AUC0-t, AUC0-∞and Cmax, all ranged from 80. 00% to 125. 00% . CONCLUSION: The test preparation of acetabone acetate tablets is bioequiva-lent to the reference preparation after diet.关键词
醋酸阿比特龙/健康人/生物等效性/LC-MS/MSKey words
abiraterone acetate/healthy volun-teers/bioequivalence/LC-MS/MS分类
医药卫生引用本文复制引用
刘亚男,阳国平,裴奇,王逸雅,焦菲菲,阳晓燕,杨双,郭灿,黄洁..高变异药物醋酸阿比特龙片人体生物等效性评价[J].中国临床药理学与治疗学,2018,23(10):1141-1146,6.基金项目
湖南省科技计划立项(2015TP2005) （2015TP2005）
