摘要
对法莫替丁缓释片在１６名健康志愿者体内的生物利用度进行了研究。以高效液相色谱法测定血药浓度，依据美国药典２３版中关于生物等效性指南的有关要求处理数据。结果表明：单剂量给药，本品的达峰时间为８１３±０３４ｈ，峰浓度为６９５２±３００ｎｇ／ｍｌ，相对生物利用度为１１２４±８６％；多剂量给药达稳态后，本品的峰浓度为８６１４±２９５ｎｇ／ｍｌ，血药浓度波动度为１４０６±１３５％。对ＡＵＣ进行双单侧检验的结果证明本品与市售普通片生物等效。
The relative bioavailability of famotidine sustained release (SR) tablets was studied in 16 healthy male volunteers. Famotidine plasma concentration was determined by HPLC method, and the plasma concentration time data were processed with the method provided by USP XXIII. For single dose administration the peak plasma concentration occurring at 8 13±0 34 h was 69 52±3 00 ng/ml and the relative bioavailability was 112 4±8 6%. For multiple dose administration the peak plasma concentration of SR tablet was 86 14±2 95 ng/ml and the degree of fluctuation (DF) was 140 6±13 5% at steady state. Two one sided tests were performed in bioequivalence assessment. The results showed that the sustained release tablets were basically bioequivalent to the immediate release (IR) tablets on sale.
