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１８名健康男性志愿者交叉单剂量口服杭州默沙东产５０ｍｇ氯沙坦钾片和英国默克产５０ｍｇ氯沙坦钾片，以ＨＰＬＣ－ＵＶ 法测定血浆中氯沙坦钾及其活性代谢产物Ｅ－３１７４的浓度，并对两种制剂进行生物等效性评价。试验结果表明：口服杭州产及默克产氯沙坦钾，氯沙坦钾Ｃ_（ｍａｘ）分别为３５２．２０１± １９６．０９和２９１．２０±１２４．４１μｇ·Ｌ~（－１），Ｔ_（ｍａｘ）分别为０．９１±０．３８和１．３３±０．６９ｈ，ＡＵＣＯ_（０－∞）分别为５４７．４４±２２６．７７和４９９．５２±１５７．３１μｇ·ｈ·Ｌ~（－１）， Ｔ_（１／２）；、分别为１．８９±０４９和１．８０±０．５１ｈ； Ｅ－３１７４ Ｃ_（ｍａｘ）分别为５４５．０７±１５０．４９和５３４．０２±１４２．８８μｇ·Ｌ~（－１），Ｔ_（ｍａｘ）分别为３．１５±１．０７和３．３７±０．６６ｈ，ＡＵＣ_（０－∞）分别为３６４１．５７ ± ６３７．１７和３６３１．７２ ± ６８７．９４μｇ·ｈ·Ｌ~（－１），Ｔ_（１／２）分别为８．３３±２．０５和７７４±１．２２ｈ。统计分析表明，两制剂间氯沙坦钾的Ｃ_（ｍａｘ）、Ｔ_（ｍａｘ）有显著差异，而氯沙坦钾的ＡＵＣ_（０－∞）、Ｅ－３１７４?
Eighteen healthy male volunteers crossed the single oral dose of 50 mg Losartan potassium tablets in Hangzhou Merck and 50 mg losartan potassium tablets in the United Kingdom to determine the content of losartan potassium and its active metabolite E- 3174, and bioequivalence was evaluated for both formulations. The results showed that the maximal values of Losartan and losartan potassium in oral Hangzhou and Merck were 352.201 ± 196.09 and 291.20 ± 124.41μg · L -1, (Max) were 0.91 ± 0.38 and 1.33 ± 0.69 h, respectively. The AUCO_ (0-∞) were 547.44 ± 226.77 and 499.52 ± 157.31 μg · h · L ~ -1), T_ (1/2); 1.89 ± 049 and 1.80 ± 0.51h respectively; E-3174 C_max were 545.07 ± 150.49 and 534.02 ± 142 .88 μg · L -1, T max were 3.15 ± 1.07 and 3.37 ± 0.66 h, respectively. The AUC_ (0-∞) were 3641.57 ± 637.17 and 3631, respectively. 72 ± 687.94μg · h · L -1, T 1/2 was 8.33 ± 2.05 and 77 respectively 4 ± 1.22h. Statistical analysis showed that losartan potassium had significant difference in C max and T max between the two preparations, while losartan potassium AUC 0- ∞, E-3174?