中国临床药理学杂志Issue(3)：227-229,3.DOI:10.13699/j.cnki.1001-6821.2016.03.011
饮食对谱圣康口服液在健康人体的药代动力学的研究
Effect of diet on the pharmacokinetic of Picika oral solution in healthy human
段锋 1魏振满 1朱珍真 1毕京峰 1陈本超 1陈贞 1张丽 1姬慧 1郎丽巍 1王敏1
作者信息
- 1. 中国人民解放军第三〇二医院 新药临床试验中心，北京 100039
- 折叠
摘要
Abstract
Objective To study the influence of diet on the pharmacoki-netic of Picika oral solution in healthy subjects.Methods This study taken random , before and after self-control design.Twelve subjects were randomly divided into 2 groups, each group was 6 cases, then they were given Picika oral solution 60 mL respectively before and after meal.Before and after administration , blood and urine samples were collected at different points , the plasma and urine concentration was measured and pharmacokinetic parameters were calculated.Results Before and after administration of Picika oral solution 60 mL, the drug pharmacokinetic parameters of active ingredients -CKL-A03 were listed as follows:t1/2 was ( 126.13 ± 74.04 ) , ( 104.81 ± 68.44 ) min; tmax were (53.75 ±10.03 ) and (58.75 ±11.89 ) min;Cmax were (3.06 ±0.86 ) and ( 3.81 ±2.82 )μg· L-1; AUC0-t were ( 268.81 ±84.25 ) and (355.03 ±177.82 )μg· L-1 · min in plasma respectively.t1/2 was (1.14 ± 0.12 ), ( 1.24 ± 0.16 ) h in the urine respectively.Conclusion Diet may affect the absorption and eliminate speed of the drug.关键词
谱圣康口服液/饮食试验/药代动力学/Ⅰ期临床试验/自身对照Key words
Picika oral solution/diet test/pharmacokinetic/phase Ⅰclinical trial/self-control分类
医药卫生引用本文复制引用
段锋,魏振满,朱珍真,毕京峰,陈本超,陈贞,张丽,姬慧,郎丽巍,王敏..饮食对谱圣康口服液在健康人体的药代动力学的研究[J].中国临床药理学杂志,2016,(3):227-229,3.
