两种法莫替丁胶囊在人体内的药代动力学与生物等效性研究

Pharmacokinetics and Bioavailability of Two Kinds of Famotidine Capsule in Healthy Volunteers

目的 :研究不同厂家生产的两种法莫替丁胶囊在健康志愿者体内的药代动力学 ,并评价这两种制剂的生物等效性。方法 :20例健康成年男性志愿者随机单次口服40mg法莫替丁胶囊后 ,采用固相萃取反相高效液相色谱法测定血浆中法莫替丁的浓度。结果 :参比制剂与受试制剂的主要药代动力学参数Cmax 分别为 (189 9±72 1) μg/L、(170 1±59 6) μg/L ;Tmax 分别为 (2 5±0 8)h、(2 1±0 8)h ;T1/2 分别为 (4 1±0 9)h、(3 8±0 8)h ;AUC0～t 分别为 (1031 7±316 7) μg/(L·h)、(1019 4±290 5) μg/(L·h) ;AUC0→∞分别为 (1123 9±346 0) μg/ (L·h)、(1103 4±312 0) μg/ (L·h) ;受试制剂相对于参比制剂的人体生物利用度为(101 6±22 6) %。结论 :受试制剂与参比制剂生物等效。

OBJECTIVE:To study the pharmacokinetics of two kinds of famotidine capsule from different factories in healthy volunteers and to evaluate the bioavailability of them METHODS:A single oral 40 mg dose of famotidine capsule of reference or test preparation was given to healthy male volunteers according to an open randomized crossover study The plasma concentrations of famotidine were determined by a RP-HPLC method The pharmacokinetic parameters and bioavailability of test preparation were compared with reference preparation RESULTS:The main pharmacokinetic parameters of the reference preparation and the test preparation were as follows:Cmax were(189 9±72 1)μg/L and(170 1±59 6)μg/L;Tmax were(2 5±0 8)h and (2 1±0 8)h;T1/2 were(4 1±0 9)h and(3 8±0 8)h;AUC0～t were (1 031 7±316 7)μg/(L·h)and(1 019 4±290 5)μg/(L·h);AUC0→∞ were(1 123 9±346 0)μg/(L·h)and(1 103 4±312 0)μg/(L·h);The relative bioavailability of reference to test preparation was(101 6±22 6)% CONCLUSION:The results showed that the reference preparation and the test preparation were bioequivalent