医学
药代动力学
加药
早晨
甘油三酯
二十碳五烯酸
最大值
不利影响
口服
内科学
胃肠病学
药理学
脂肪酸
胆固醇
有机化学
化学
多不饱和脂肪酸
作者
Yuan Fang,Hui Li,Mengjie Yang,Weili Chen,Hanjing Chen,Hongtao Xu,Jing Li,Lei Sheng,Chao Liu,Ye Li,Huan Li,Xuening Li
摘要
Icosapent ethyl (IPE) is a high-purity prescription form of eicosapentaenoic acid (EPA) ethyl ester that has been approved to lower triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Before this study, there were no pharmacokinetics (PK) or safety data in Chinese patients after receiving IPE. The purpose of this study was to evaluate the PK of EPA in plasma and red blood cells and safety after oral administration of IPE capsules for 28 consecutive days in healthy Chinese subjects. It was a randomized, open-label, parallel-designed multiple-dose, phase I study. Twenty-four subjects were enrolled and randomly assigned to 2 groups, including 6 men and 6 women in each group. Group A received IPE 2.0 g/day (1×1 g twice daily), and group B received IPE 4.0 g/day (2×1 g twice daily) with dosing after standard meals for 28 days. During the treatment period, PK samples were collected from all subjects before the morning dose on days 1, 14, 26, and 28. Following completion of the last study drug administration in the morning on day 28, an 18-day posttreatment PK sample collection period was followed. Twenty-four eligible subjects were enrolled in this study, and 1 subject withdrew from the study. The main PK parameters (baseline-corrected maximum observed plasma concentration and area under the plasma concentration-time curve during a dosing interval) of plasma total EPA, RBC EPA, and plasma unesterified EPA increased with dose. Chinese healthy subjects who took IPE capsules orally in the dose range of 2.0 to 4.0 g/day for 28 consecutive days were safe and tolerable.
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