Pharmacokinetics and Safety of Ezetimibe/simvastatin Combination Tablet:An Open-label, Single-dose Study in Healthy Chinese Volunteers
Background and objective:Ezetimibe/simvastatin combination tablet has been approved for the treatment of high LDL-C (Low-density-lipoprotein cholesterol) levels in patients with primary hypercholesterolemia or mixed hypercholesterolemia as adjunctive therapy to diet,when diet alone is insufficient in lowering cholesterol.The aims of this study were to assess the pharmacokinetics and safety of ezetimibe/simvastatin combination tablet after oral single-dose administration in healthy Chinese volunteers including sex differences in pharmacokinetics.Methods:This was an open-label,single-dose study.Twelve healthy subjects (6 male and 6 female) received a single dose of ezetimibe/simvastatin combination tablet (including 10 mg ezetimibe and 40 mg simvastatin).The pharmacokinetic parameters for ezetimibe and simvastatin were assessed by determining total ezetimibe,free ezetimibe,simvastatin and simvastatin acid concentrations using a validated LC-MS/MS (Liquid chromatography-tandem mass spectrometry) method.Safety was evaluated by monitoring adverse events,laboratory assays,vital signs,physical examinations and 12-lead electrocardiograms.
Nan-Nan Chu Wei-Li Chen Hong-Rong Xu Xue-Ning Li
Department of Clinical Pharmacology, ZhongShan Hospital, Fudan University, Shanghai, China
国内会议
成都
英文
349-350
2012-10-26（万方平台首次上网日期，不代表论文的发表时间）