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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 bioavailability of famotidine extended-release tablets in 16 healthy volunteers was studied. The plasma concentration was determined by HPLC and the data were processed according to the relevant requirements of the U.S. Pharmacopeia, Version 23, Bioequivalence Guidelines. The results showed that the peak time of this product was 813 ± 034h, the peak concentration was 6952 ± 300ng / ml and the relative bioavailability was 1124 ± 86%. After the multi-dose administration reaches the steady state, the peak concentration of the product is 86.14 ± 2.95ng / ml, and the plasma concentration fluctuation is 140.6 ± 13.5%. The result of double unilateral test on AUC proves that this product is bioequivalent to the common tablets on the market.