Bioequivalence study of pitavastatin calcium dispersible tablets in healthy Chinese volunteers
10.13699/j.cnki.1001-6821.2024.10.022
- VernacularTitle:匹伐他汀钙分散片在中国健康受试者的生物等效性研究
- Author:
Wei ZHANG
1
;
Chun-Miao PAN
;
Xiao-Dan WANG
;
Yin HU
;
Rong SHAO
;
Bo JIANG
Author Information
1. 浙江大学医学院附属第二医院临床药理中心,浙江杭州 310009
- Keywords:
pitavastatin calcium dispersible tablet;
high performance liquid chromatography-tandem mass spectrometry;
pharmacokinetics;
bioequivalence
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(10):1497-1501
- CountryChina
- Language:Chinese
-
Abstract:
Objective To compare the bioavailability and bioequivalence of pivastatin calcium dispersive tablets in healthy Chinese subjects.Methods A single dose of pitavastatin calcium(2 mg)was orally administered to the test preparation or reference preparation under fasting and postprandial conditions,respectively.The plasma concentrations of pitavastatin calcium were measured at different time points before and after administration by high performance liquid chromatography-tandem mass spectrometry(HPLC-MS/MS).The bioequivalence of the two formulations was evaluated.Results Subjects received pitavastatin calcium test preparation and reference preparation in fasting condition,the Cmax were(47.79±23.99)and(46.03±21.82)ng·L-1;AUC0_,were(96.56±42.64)and(97.96±35.40)ng·h·L-1;AUC0_∞ were(102.09±43.01)and(103.46±35.62)ng·h·L-1,respectively.The 90％confidence intervals of the geometric mean ratios of Cmax,AUC0_t and AUC0-∞ of pitavastin-calcium test formulation and reference formulation were 96.28％-111.16％,94.46％-101.19％and 94.77％-101.31％,respectively.Subjects received pitavastatin calcium test preparation and reference preparation in fasting condition,the Cmax were(27.32±10.68)and(28.58±11.39)ng·L-1;AUC0_t were(82.76±27.58)and(84.06±29.12)ng·h·L-1;AUC0_∞ were(87.88±26.93)and(89.29±29.18)ng·h·L-1,respectively.The 90％confidence intervals of the geometric mean ratios of Cmax,AUC0_t and AUC0_∞ of the test formulation and the reference formulation of pitavastatin calcium were 87.39％-102.10％,94.62％-101.34％and 94.88％-101.47％,respectively.All of them were within the bioequivalence range of 80.00％to 125.00％.Conclusion Two pivastatin calcium dispersion tablets were bioequivalent and safe in healthy Chinese adult subjects.
