[Translation] A single-center, randomized, open-label, two-period, two-sequence, double-crossover, single-dose bioequivalence study of silodosin tablets in healthy volunteers with fasting or postprandial diet
本研究以北京爱力佳医药科技有限公司的赛洛多辛片为受试制剂,以原研厂家キッセイ薬品工業株式会社生产的赛洛多辛片为参比制剂,评估受试制剂和参比制剂在空腹/餐后条件下给药后的生物等效性。并观察受试制剂赛洛多辛片和参比制剂赛洛多辛片在健康受试者中的安全性。
[Translation] In this study, silodosin tablets produced by Beijing Ailijia Pharmaceutical Technology Co., Ltd. were used as the test preparation, and silodosin tablets produced by the original manufacturer, Kobe Industry Co., Ltd. were used as the reference preparation to evaluate the test preparation and the reference preparation. Bioequivalence after dosing under fasting/prandial conditions. And observe the safety of the test preparation silodosin tablets and the reference preparation silodosin tablets in healthy subjects.