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健康志愿者 9名采用三交叉设计分别口服 50 0 mg国产西安制药厂克拉霉素片剂 A,丽珠制药厂克拉霉素片剂 B(2 50 mg/片 )及进口克拉霉素片 (KL ACID,2 50 mg/片 )。克拉霉素的血药浓度用微生物法进行测定。这三种制剂血药药浓度 -时间过程十分相似 ,符合开放二室模型。片剂 A、B与 KAL CID的药动学参数如下 :Tmax分别为 (2 .0 6± 0 .3 0 )、(2 .11± 0 .42 )及 (1.89±0 .3 3 ) h;Cmax分别为 (2 .47± 0 .3 0 )、(2 .63± 0 .2 5)及 (2 .64± 0 .3 3 ) mg/ L;AUC分别为 (2 1.50± 3 .53 )、(19.10± 2 .3 9)及 (19.92±2 .63 ) mg· h/ L。以 KL ACD作为参考标准 (生物利用度为 10 0 % ) ,A、B片剂的相对生物利用度分别为 10 7.9%与 95.9%。本试验的药动学参数与文献报道日本志愿者相仿 ,但与西方志愿者相比存在很大差异 ,值得进一步研究
Nine healthy volunteers were treated with clarithromycin Tablets A, Clarithromycin Tablets B (250 mg / tablet) and imported clarithromycin tablets (KL ACID, 2 50 mg / tablet). Plasma concentrations of clarithromycin were determined by the microbial method. The three preparations blood drug concentration-time course is very similar to meet the open two-compartment model. The pharmacokinetic parameters of tablets A, B and KAL CID were as follows: Tmax were (2.06 ± 0.30), (2.11 ± 0.42) and (1.89 ± 0.33) h respectively; Cmax were (2.47 ± 0.30), (2.63 ± 0.52) and (2.64 ± 0.33) mg / L, respectively; AUC were (2.50 ± 3.53) , (19.10 ± 2.39) and (19.92 ± 2.63) mg · h / L, respectively. Using KL ACD as the reference standard (bioavailability was 10%), the relative bioavailability of tablets A and B were 10 7.9% and 95.9%, respectively. The pharmacokinetic parameters of this study are similar to those reported by Japanese volunteers, but there are great differences compared with western volunteers, which deserve further study