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１２名男性健康志愿者随机交叉口服单剂量４０ ｍｇ辛伐他汀胶囊和辛伐他汀片后，用高效液相色谱法检测血浆中辛伐他汀浓度，进行药代动力学和相对生物利用度研究。试验结果表明，口服辛伐他汀的体内过程符合一房室模型，胶囊和片剂的药代动力学参数分别为：Ｔ_１／２为２．３９±０．４３ ｈ和２．２０±０．４５；Ｔ_ｍａｘ为１．９２±０．３６ ｈ和 １．７９ ± ０．４５ ｈ； Ｃ_ｍａｘ为 ７．９６ ± ２．７３ ｍｇ· Ｌ~－１和 ８．３３ ± ３．６２ｍｇ· Ｌ~－１；Ａ ＵＣ_０－１０为２５．２１± ８．２９ ｍｇ·ｈ·Ｌ~－１和２５．９９ ± ７．８５ ｍｇ·ｈ·Ｌ~－１。相对生物利用度为９６．９±１３．０％，主要药代动力学参数经对数转换后采用方差分析和双单侧 ｔ检验进行分析，结果显示两种辛伐他汀制剂具有生物等效。
Twelve male healthy volunteers were randomized to receive a single dose of 40 mg simvastatin capsules and simvastatin tablets. Plasma concentrations of simvastatin were measured by HPLC, and pharmacokinetics and relative bioavailability were studied. The experimental results showed that the in vivo process of simvastatin orally conformed to a one-compartment model. The pharmacokinetic parameters of capsules and tablets were: T 1/2 2.39 ± 0.43 h and 2.20 ± 0.45 ; T_max was 1.92 ± 0.36 h and 1.79 ± 0.45 h; C_max was 7.96 ± 2.73 mg · L -1 and 8.33 ± 3.62 mg · L -1; A UC_0-10 was 25.21 ± 8.29 mg · h · L -1 and 25.99 ± 7.85 mg · h · L -1. The relative bioavailability was 96.9 ± 13.0%. The main pharmacokinetic parameters were log transformed and analyzed by analysis of variance and double unilateral t-test. The results showed that the two simvastatin formulations were bioequivalent.