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本研究是通过８名中国健康受试者对国产克拉霉素胶囊和颗粒剂与进口片剂进行人体药代动力学和相对生物利用度试验。血药浓度测定采用生物检定法。结果片剂、胶囊和颗粒剂三种制剂的药时曲线符合一房室模型，主要药代动力学参数分别为：Ｃｍａｘ２．２４±０．５３，２．０９±０．５６，２．５８±０．５８ｍｇ·Ｌ－１；Ｔｍａｘ１．７２±０．７３，２．１４±０．９７，０．６８±０．２０ｈ；Ｔ１／２４．９６±０．５１，４．５９±０．８９，４．７８±０．６７ｈ；药时曲线下面积ＡＵＣ０－ｔ平均值：１９．３９±３．１４，１８．４５±４．１２，１８．８２±２．９１ｍｇ·ｈ·Ｌ－１；相对生物利用度为：胶囊９２．４８±１６．５０％，颗粒剂１０１．３４±１６．２６％。试验结果经统计学处理均证明：受试的克拉霉素胶囊和颗粒剂与对照制剂为生物等效制剂。
In this study, eight Chinese healthy subjects were tested for domestic pharmacokinetics and relative bioavailability of domestic clarithromycin capsules and granules and imported tablets. Blood concentration determination using biological assay. Results The pharmacokinetic profiles of the three formulations of tablets, capsules and granules were in accordance with one-compartment model. The main pharmacokinetic parameters were Cmax2.24 ± 0.53, 2.09 ± 0.56 and 2.58 ± 0.58 mg · L-1; Tmax 1.72 ± 0.73, 2.14 ± 0.97, 0.68 ± 0.20 h; T1 / 24.96 ± 0.51, 4.59 ± 0.89, 4.78 ± 0.67h; the average AUC0-t area under the curve of drug: 19.39 ± 3.14,18.45 ± 4.12,18.82 ± 2.91mg · h · L-1; relative Bioavailability: capsule 92.48 ± 16.50%, granules 101.34 ± 16.26%. The results of the test showed that all the clarithromycin capsules and granules tested were bioequivalent.