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采用微生物管碟检定法，以短小芽孢杆菌ＣＭＣＣ（Ｂ）６３２０２为检定菌，测定了１２名男性健康受试者口服克拉霉素（ＣＲＭ）胶囊（被试制剂）和片剂（标准对照制剂）后不同时刻血浆中活性药物的浓度，绘制了血药浓度－时间曲线。受试者交叉口服含ＣＲＭ５００ｍｇ的被试制剂和标准对照制剂后，血浆药物浓度达峰时间分别为１．３９±０．７４和１．１６±０．４１ｈ，血浆药物浓度峰值分别为２．５４±０．６２和２．７１±０．６１μｇ／ｍｌ，消除半衰期分别为４．５９±０．９９和４．７２±０．８５ｈ，用梯形法计算，ＡＵＣ０→∞分别为２１．７０±２．７１和２２．４２±３．５３ｈμｇ／ｍｌ。被试制剂中ＣＲＭ的相对生物利用度平均为（９９．３±１０．３）％，经统计学分析与对照制剂生物等效。两种制剂中ＣＲＭ的药动学过程均符合一室开放模型
A total of 12 male healthy volunteers were tested for oral administration of clarithromycin (CRM) capsule (test preparation) and tablets (standard control preparation) by using Microtuber assay and Bacillus pumilus CMCC (B) 63202 as test bacteria. After different times the concentration of active drug in plasma, the blood concentration-time curve was plotted. Subjects crossed with oral administration of CRM500mg test preparation and standard control preparations, the plasma drug concentration peak time were 1.39 ± 0.74 and 1.16 ± 0.41h, plasma drug concentration peaks were 2.54 ± 0.62 and 2.71 ± 0.61μg / ml respectively, and the elimination half-lives were 4.59 ± 0.99 and 4.72 ± 0.85h, respectively. The calculated AUC0 → ∞ was 21.70 ± 2 .71 and 22.42 ± 3.53 h μg / ml. The relative bioavailability of CRM in the test preparations averaged (99.3 ± 10.3)% and was bioequivalent to the control formulation by statistical analysis. The pharmacokinetics of CRM in both formulations is in line with the open-chamber model