李坤艳 1仇宇 1蒋云 1罗晨辉 1杨农 1林小平 1周春花 1王静1
作者信息
- 1. 湖南省肿瘤医院 中南大学湘雅医学院附属肿瘤医院GCP中心，长沙 410006
- 折叠
摘要
Abstract
Objective To investigate pharmacokinetic characters of olmesartan medoxomil in healthy Chinese subjects after single and multiple administrations. Methods A single dose experiment:12 screening qualified subjects,the test wass divided into three groups by randomized-sequence,single-dose,3-treatment,3-period crossover design,each group of 4 peoples,each cycle respectively corresponding to the dose of drugs,and each cycle after 7 d washout period before taking the medicine.Multiple dosing test:12 healthy subjects were given 20 mg olmesartan medoxomil every day,contin-uous 4 d.Collected 0 h before taking the medicine and medication after blood analysis within 48 h of drugs in vivo PK parameters. Results Single dose olmesartan medoxomil (20,40,80 mg) after the maximum concentration in plasma (Cmax) were respectively (1016±349),(1503±266),(2516±1196) ng/ml,1/2 level elimination half-life (t1/2) for (5.2±1.2),(5.6±1.6), (6.2±0.9) h,after multiple dose olmesartan medoxomil,the Cmax and t1/2 was (894±301) ng/ml,(6.4±1.2) h respectively,sin-gle dose and t1/2 level differences between multiple dosing has no statistical significance.A single dose experiment,when within 20 to 80 mg dose,AUC0-∞,AUC0-48 and Cmax PK parameters with a linear relationship between dose of drug. Con-clusion Olmesartan medoxomil has no accumulation in healthy Chinese subjects after 20 mg multiple-dose.关键词
奥美沙坦酯/药代动力学/中国人Key words
Olmesartan medoxomil/Pharmacokinetics/Chinese分类
医药卫生
