中国临床药理学杂志2024，Vol.40Issue(5)：718-722,5.DOI:10.13699/j.cnki.1001-6821.2024.05.018
依托考昔片在中国健康受试者中的生物等效性研究
Bioequivalence study of etoricoxib tablets in healthy Chinese subjects
焦珍珍 1许莉 1刘曼 1胡天泽 1宋丹 1王晓娟 1赵志晶 1刘会臣1
作者信息
- 1. 中国医学科学院阜外医院、国家心血管病中心、国家心血管疾病临床医学研究中心Ⅰ期临床试验病房、国家卫生健康委员会心血管药物临床研究重点实验室,北京 100037
- 折叠
摘要
Abstract
Objective To study the pharmacokinetic characteristics of etoricoxib tablets in healthy Chinese subjects and to evaluate the bioequivalence and safety of the test and reference formulations.Methods In a randomised,single-dose,two-period,two-sequence crossover trial,28 healthy subjects were enrolled under the fasting and fed conditions,respectively,who received a single oral dose of 60 mg of etoricoxib tablets in the test or reference formulation.The concentration of etoricoxib in plasma was detected by LC-MS/MS,and the main pharmacokinetic parameters were calculated to evaluate bioequivalence and using WinNonlin 8.2 software.Results The main pharmacokinetic parameters of the test and reference preparations were as follows:The fasting condition Cmax of etoricoxib were(1 176.96±287.95)and(1 164.93±189.65)ng·mL-1;AUC0-t were(18 651.95±6 100.27)and(19 241.39±6 107.48)ng·h·mL-1;and AUC0-∞ were(19 939.15±7 553.27)and(20 536.31±7 223.40)ng·h·mL-1.The fed condition Cmax of etoricoxib were(913.50±184.72)and(878.59±164.35)ng·mL-1;and AUC0-t were(19 085.22±5 155.01)and(18 669.54±4 508.21)ng·h·mL-1;AUC0-∞ were(20 103.77±5 567.02)and(19 528.05±4 989.74)ng·h·mL-1.The 90％confidence intervals for the geometric mean ratios of the main pharmacokinetic parameters in the fasting and fed conditions fell between 80.00％and 125.00％.The incidence of adverse events in the fasting and fed conditions were 28.57％and 21.43％,respectively.Conclusion Two kinds of etoricoxib tablets are bioequivalent,and have similar safety in healthy Chinese subjects.关键词
依托考昔片/健康受试者/生物等效性/药代动力学/液相色谱-串联质谱法Key words
etoricoxib tablets/healthy subject/bioequivalence/pharmacokinetics/liquid chromatography-tandem mass spectrometry(LC-MS/MS)分类
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焦珍珍,许莉,刘曼,胡天泽,宋丹,王晓娟,赵志晶,刘会臣..依托考昔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(5):718-722,5.
