[Translation] Randomized, open-label, two-cycle, two-sequence, crossover design bioequivalence trial protocol for single oral administration of toremifene citrate tablets in healthy adult subjects in the fasting state and after a high-fat meal
主要研究目的:研究重庆圣华曦药业股份有限公司生产的枸橼酸托瑞米芬片(规格:60mg)在中国健康受试者中空腹状态及高脂餐后以口服途径单次给药的药代动力学特征,并以 Orion Corporation 持有,Orion Corporation 生产的枸橼酸托瑞米芬片(商品名:法
乐通®、FARESTON®;规格:60mg)为参比制剂,进行生物等效性评价。次要研究目的:初步考察枸橼酸托瑞米芬片受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main research purpose: To study the efficacy of toremifene citrate tablets (specification: 60 mg) produced by Chongqing Shenghuaxi Pharmaceutical Co., Ltd. in Chinese healthy subjects after a single oral administration on an empty stomach and after a high-fat meal. The pharmacokinetic characteristics of toremifene citrate tablets (trade name: Toremifene Citrate Tablets) produced by Orion Corporation are
Letong®, FARESTON®; specification: 60mg) are reference preparations for bioequivalence evaluation. Secondary research purpose: Preliminarily investigate the safety of the test preparation and reference preparation of toremifene citrate tablets in healthy subjects.