The effect of food on the pharmacokinetic properties and bioequivalence of two formulation of pitavastatin calcium in healthy Chinese male subjects
1.Pitavastatin is an effective treatment for primary hyperlipidemia and mixed dyslipidemia.The aim of the present study was to investigate the effect of food on the pharmacokinetic properties and bioequivalence of the original,branded,formulation of pitavastatin calcium and a new generic formulation in healthy Chinese male subjects under fasting and fed conditions.2.Under fasting and fed conditions,90%CIs of the geometric mean of generic/branded AUC0–48 h ratios were 92.2–102.4%,93.1–104.5%,the ratios of ln(AUC0–1)were 92.6–103.7%,93.2–103.5%,and ln(Cmax)ratios were 90.7–110.3%,84.7–100.8%,respectively.The generic and branded formulations were bioequivalent in terms of rate and extent of absorption under both the conditions.The average values of AUC0–48 h,AUC0–1 and Cmax decreased noticeably following a high-fat breakfast.Values for AUC0–48 h were 87.69%and 83.7%,values for AUC0–1 were 87.5%and 84.6%,and values for Cmax were 45.0%and 50.4%in subjects given the generic and branded preparations,respectively.The absorption of 3.Both formulations were generally well tolerated,with no serious adverse reactions reported.The newly developed generic formulation may provide a reliable alternative to the branded tablets for patients with primary hyperlipidemia or mixed dyslipidemia.
Dewei Shang Shuhua Deng Zhenhong Yao Zhanzhang Wang Xiaojia Ni Ming Zhang Jinqing Hu Haoyang Lu Xiuqing Zhu Wencan Huang Chang Qiu Yuguan Wen
Institution of National Drug Clinical Trials of Guangzhou Brain Hospital(Guangzhou Huiai Hospital,Th HaiNan HuaLon Pharmaceutical Co.,Ltd.,Hainan,PR China
国内会议
广州
英文
1-24
2016-12-17（万方平台首次上网日期，不代表论文的发表时间）