中国临床药理学杂志2017，Vol.33Issue(7)：605-608,4.DOI:10.13699/j.cnki.1001-6821.2017.07.009
甲磺酸伊马替尼片在中国健康男性受试者的生物等效性研究
Bioequivalence of imatinib tablets in Chinese healthy male subjects
刘静 1赵文操 2徐为人 2李劲彤3
作者信息
- 1. 天津医科大学基础医学院,天津300070
- 2. 泰达国际心血管病医院Ⅰ期临床试验研究室,天津300457
- 3. 天津药物研究院,天津300193
- 折叠
摘要
Abstract
Objective To evaluate the bioequivalence of the two imatinib tablets in Chinese healthy male subjects.Methods A single oral dose 400mg of test and reference imatinib tablets were given to 30 subjects according to an open randomized crossover design.The concentrations of imatinib in plasma were determined by LC-MS/MS.The pharmacokinetic parameters were calculated and the bioequivalence was compared by non-compartment model of WinNonlin 6.3 program.Results The main pharmacokinetic parameters of imatinib of the test and reference preparations were as follows:Cmax were (1840.00 ± 749.00),(1950.00 ±635.00)ng · mL-1;tmax were(2.98 ±1.41),(2.38 ±0.94) h;t1/2 were (15.80±3.39),(15.30 ±3.02)h;AUC0-t were (30.60 ±9.57),(32.00 ± 8.23) mg · mL-1 · h;AUC0-∞ were (31.90 ± 10.20),(33.20-±8.46)rag · mL-1 · 1.The 90％ confidential interval of AUC0-t,AUC0-∞ and Cmax of tested formulation were 89.00％-100.50％,89.00％-100.90％ and 86.30％-100.60％ The relative bioavailability of imatinib of test preparations were as follows:AUC0-t was (96.20 ± 17.20) ％,AUC0-∞ was (96.60 ± 17.90) ％.Conclusion The two preparations were bioequivalent.关键词
甲磺酸伊马替尼/LC-MS/MS/生物等效性/药代动力学Key words
imatinib/LC-MS/MS/bioequivalence/pharmacokinetics分类
医药卫生引用本文复制引用
刘静,赵文操,徐为人,李劲彤..甲磺酸伊马替尼片在中国健康男性受试者的生物等效性研究[J].中国临床药理学杂志,2017,33(7):605-608,4.
