目的 :研究克拉霉素颗粒剂在健康人体内的药动学和相对生物利用度。方法 :8名健康男性受试者 ,采用随机交叉试验设计 ,单剂量口服克拉霉素颗粒剂和片剂 5 0 0mg ,用微生物检定法测定血药浓度。经 3p97程序拟合 ,计算药动学参数。 结果 :克拉霉素颗粒剂和片剂的药 时曲线均符合二室模型 ,主要药动学参数 :t1/ 2 β分别为 (6 .9± 4.0 )h和 (7.9± 3.8)h ;tmax分别为 (1.4± 0 .3)h和 (1.4± 0 .4)h ;Cmax分别为 (2 .1± 0 .3)mg·L-1和 (2 .0± 0 .4)mg·L-1;AUC0→∞ 分别为 (11.6± 1.6 )h·mg·L-1和 (11.3± 1.4)h·mg·L-1。经统计学分析 ,两制剂的tmax、Cmax、AUC0→∞ 差异均无显著性 (P >0 .0 5 ) ,克拉霉素颗粒剂的相对生物利用度为 (10 4.1± 2 1.3) %。结论 :两制剂具有生物等效性 Objective: To study the pharmacokinetics and relative bioavailability of clarithromycin granules in healthy volunteers. Methods: Eight healthy male subjects were randomized to receive a crossover study. A single oral dose of 500 mg clarithromycin granules and 500 mg tablets was given to determine the plasma concentration of the drug. After 3p97 program fitting, calculate pharmacokinetic parameters. RESULTS: The pharmacokinetic parameters of clarithromycin granules and tablets were in accordance with the two-compartment model. The main pharmacokinetic parameters were: t1 / 2 β (6.9 ± 4.0) h and (7.9 ± 3.8) h respectively; tmax (1.4 ± 0.3 h) and (1.4 ± 0.4 h), respectively; Cmax was (2.1 ± 0.3) mg · L-1 and (2.0 ± 0.4) mg · L- 1; AUC0 → ∞ were (11.6 ± 1.6) h · mg · L-1 and (11.3 ± 1.4) h · mg · L-1, respectively. The statistical analysis showed that there was no significant difference in tmax, Cmax, AUC0 → ∞ between the two preparations (P> 0.05), and the relative bioavailability of clarithromycin granules was (10 4.1 ± 2.1 1.3)%. Conclusion: The two preparations are bioequivalent