Bioequivalence study of cilostazol tablets in Chinese healthy subjects
10.13699/j.cnki.1001-6821.2024.16.017
- VernacularTitle:西洛他唑片在中国健康受试者中的生物等效性研究
- Author:
Yan-Rong WANG
1
;
Ying-Zi PEI
;
Ran CHEN
;
Ying WANG
;
Ming-Yue XIE
Author Information
1. 沧州市中心医院药物临床试验机构办公室,河北沧州 061017
- Keywords:
cilostazol tablet;
healthy volunteers;
bioequivalence;
pharmacokinetics;
liquid chromatography tandem mass spectrometry
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(16):2383-2387
- CountryChina
- Language:Chinese
-
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.