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.
