中国临床药理学杂志2024，Vol.40Issue(16)：2383-2387,5.DOI:10.13699/j.cnki.1001-6821.2024.16.017
西洛他唑片在中国健康受试者中的生物等效性研究
Bioequivalence study of cilostazol tablets in Chinese healthy subjects
王彦荣 1裴莹子 2陈然 1王莹 1解明月2
作者信息
- 1. 沧州市中心医院药物临床试验机构办公室,河北沧州 061017
- 2. 北京福元医药股份有限公司,北京 101113
- 折叠
摘要
Abstract
Objective To evaluate the bioequivalence and safety of two cilostazol tablets 50 mg in healthy Chinese subjects.Methods This study was an open-lable,randomized,two-period crossover design.A total of 32 subjects respectively for fasting state were given a single oral dose of test or reference tedizolid phosphate tablets 50 mg.The plasma concentration of cilostazol was determined by liquid chromatography tandem mass spectrometry(LC-MS/MS),and the concentration-time data was processed by SAS 9.4,the model method of the non-compartmental was used to calculate the pharmacokinetic parameters of tedizolid and to evaluate the bioequivalence.Results The Cmax of cilostazol test and reference were(358.10±125.80)and(346.90±115.30)ng·mL-1;tmax were 3.50 and 4.00 h;t1/2 were(9.63±7.12)and(8.57±5.15)h;AUC0_twere(5 235.00±2 268.00)and(5 190.00±1 747.00)h·ng·mL-1;AUC0-∞ were(5 377.00±2 367.00)and(5 308.00±1 848.00)h·ng·mL-1.The 90％confidence intervals of the geometric mean ratios of the main pharmacokinetic parameters of the test drug and reference drug were within the range of 80.00％to 125.00％.Conclusion Single oral test and reference cilostazol tablets were bioequivalent and safe in healthy Chinese subjects.关键词
西洛他唑片/健康受试者/生物等效性/药代动力学/液相色谱-质谱法Key words
cilostazol tablet/healthy volunteers/bioequivalence/pharmacokinetics/liquid chromatography tandem mass spectrometry分类
药学引用本文复制引用
王彦荣,裴莹子,陈然,王莹,解明月..西洛他唑片在中国健康受试者中的生物等效性研究[J].中国临床药理学杂志,2024,40(16):2383-2387,5.
