中文摘要：

本文通过比较国产复方非洛地平缓释片试验制剂与同时服用非洛地平片和马来酸依那普利片两种参比制剂的药代动力学特征，采用开放、随机、自身交叉试验设计，筛选12位健康男性受试者，随机分为2组，每组6人，周期间的洗脱期为14天。我们发现与普通片剂相比，复方非洛地平缓释片中非洛地平成分具有明显的缓释特征，而另一成分依那普利及其活性代谢产物依那普利拉则无缓释效果。

英文摘要：

To compare the pharmacokinetics properties of enalapril-felodipine sustained-release tablet with enalapril and felodipine in the two reference formulations in Chinese healthy volunteers, the study was designed to a randomized, open label, crossover and two treatment pharmacokinetic study using enalapril-felodipine sustatined-release tablet as the test formulation. A total of 12 individuals were randomly assigned to 2 gorups （6 individuals in each group）. The wash-out period was 14 d. Compared with the reference formulations, felodipine in the sustained-release tablet showed significantly sustained-release characteristics, while the pharmacokinetics processes of enalapril and its active metabolite enalaprilat were basically similar in Chinese healthy volunteers.