Bioequivalence study of pyrazinamide tablets in Chinese healthy subjects
10.13699/j.cnki.1001-6821.2024.15.018
- VernacularTitle:吡嗪酰胺片在中国健康受试者中的生物等效性研究
- Author:
Li-Bing YE
1
;
Chong YAO
;
Ying-Rong CHEN
;
Lu-Yuan TONG
;
Tao YANG
;
Xiao LU
;
Min XU
;
Qiu-Yue JIN
;
Shui-Xin YANG
Author Information
1. 湖州市中心医院药学部临床试验中心,浙江湖州 313000
- Keywords:
pyrazinamide tablet;
pharmacokinetics;
bioequivalence;
liquid chromatography coupled to tandem mass spectrometry
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(15):2236-2240
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the bioequivalence and safety of two pyrazinamide tablets in healthy Chinese subjects.Methods An open,randomized,single-dose,two-sequence,two-cycle,double-cross trial design was used.All 48 healthy subjects(24 in fasting and 24 in fed trial)were randomized to receive a single oral dose of a 0.5 g pyrazinamide tablet(test or reference)per cycle.The plasma concentration of the drug was determined by liquid chromatography coupled to tandem mass spectrometry method.The pharmacokinetic parameters were calculated by WinNonlin v8.2,and the bioequivalence was evaluated by SAS 9.4.Results In the fasting group,the Cmax of the test and reference preparation of pyrazinamide tablets were(13.28±2.82)and(12.88±4.49)μg·mL-1,the AUC0-t were(139.17±26.58)and(138.63±28.92)h·μg·mL-1,the AUC0-∞ were(148.96±33.65)and(148.71±36.97)h·μg·mL-1 respectively.In the fed group,the Cmax of the test and reference preparation of pyrazinamide tablets were(11.89±1.96)and(11.99±1.92)μg·mL-1,the AUC0-t were(138.22±37.21)and(141.68±25.80)h·μg·mL-1,the AUC0-∞ were(152.20±32.41)and(151.04±28.05)h·μg·mL-,respectively.The 90％confidence intervals of Cmax,AUC0-t and AUC0-∞ geometric mean ratios of the test and reference preparation were all within 80.00％to 125.00％.The incidence of adverse events was 16.70％for both the test and reference preparation in the fasting group and 8.30％for both the test and reference preparation in the fed group,all of which were mild in severity.Conclusion The test and reference preparation of pyrazinamide tablets were bioequivalent,safe and well tolerated in healthy Chinese subjects under fasting and fed conditions.
