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目的:研究法莫替丁的药物动力学和生物等效性。方法:19名健康志愿者按双周期随机交叉试验设计口服受试制剂和参比制剂法莫替丁片,用高效液相色谱法测定血浆中法莫替丁浓度。结果:单剂量口服受试制剂和参比制剂法莫替丁片后C_(max)分别为(130.5±35.5)和(131.0±39.2)ng·ml~(-1),t_(max)分别为(2.13±0.57)和(2.29±0.75)h,AUC_(0-t)分别为(768±175)和(771±228)ng·h·ml~(-1),相对生物利用度为(99.5%±15.0)%。结论:两种法莫替丁片生物等效。
Objective: To study the pharmacokinetics and bioequivalence of famotidine. Methods: Nineteen healthy volunteers were enrolled in this study. Famotidine tablets were orally administered in a randomized crossover trial. The concentration of famotidine in plasma was determined by high performance liquid chromatography (HPLC). Results: The Cmax values were (130.5 ± 35.5) and (131.0 ± 39.2) ng · ml ~ (-1), respectively, for the single-dose oral test formulation and the reference formulation of famotidine, the t max values were (2.13 ± 0.57) and (2.29 ± 0.75) h, and the AUC_ (0-t) were (768 ± 175) and (771 ± 228) ng · h · ml -1, respectively. The relative bioavailability was (99.5 % ± 15.0)%. Conclusions: Two famotidine tablets are bioequivalent.