法莫替丁片剂在8个健康人体内的生物等效性评价

Bioequivalence assessment of famotidine tablets in 8 healthy volunteers

目的 :考察法莫替丁在正常人体内的药物动力学过程 ,评价 2种片剂的生物等效性。方法 :采用随机交叉自身对照设计 ,8例志愿受试者单剂量口服法莫替丁片A或B 4 0mg后 ,采用柱切换HPLC法测定血药浓度 ,MCPKP程序计算药物动力学参数 ,方差分析法评价生物等效性。结果 :法莫替丁的体内过程符合血管外一室开放模型 ,法莫替丁A及其对照品B的Tmax,Cmax,T12 k,AUC分别为 2 .0±s 0 .3h ,10 4± 33ng/mL ,2 .16± 0 .18h ,550± 188ng·h/mL和 2 .4± 0 .5h ,93± 2 8ng/mL ,2 .17±0 .10h ,562± 153ng·h/mL。两者间无显著性差异(P >0 .0 5)。结论 :片A与B生物等效 ,片A相对片B的生物利用度为 96%± 15%

AIM: To compare the bioequivalences between two kinds of famotidine tablets. METHODS: A crossover trial was made on 8 healthy volunteers who were dosed po with 40 mg tablet A or B. The famotidine concentrations in plasma were determined by CSHPLC methods. The pharmacokinetic parameters were calculated by MCPKP program and the bioequivalence was assessed by ANOVA. RESULTS: A one_compartment open pharmacokinetic model was adopted. The T max , C max , T 12k and AUC of tablet A and B were 2.0±s 0.3 h, 104±33 ng/mL, 2.16±0.18 h, 550±188 ng·h/mL and 2.4±0.5 h, 93±28 ng/mL, 2.17±0.10 h, 562±153 ng·h/mL, respectivly. There were no significant differences between the two tablets (P>0.05). CONCLUSION: The two kinds of famotidine tablets were bioequivalent and the average relative bioavailability of tablet A was 96%±15%.