Bioequivalence study of etoricoxib tablets in healthy Chinese subjects
10.13699/j.cnki.1001-6821.2024.05.018
- VernacularTitle:依托考昔片在中国健康受试者中的生物等效性研究
- Author:
Zhen-Zhen JIAO
1
;
Li XU
;
Man LIU
;
Tian-Ze HU
;
Dan SONG
;
Xiao-Juan WANG
;
Zhi-Jing ZHAO
;
Hui-Chen LIU
Author Information
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
- Keywords:
etoricoxib tablets;
healthy subject;
bioequivalence;
pharmacokinetics;
liquid chromatography-tandem mass spectrometry(LC-MS/MS)
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(5):718-722
- CountryChina
- Language:Chinese
-
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.
