[Translation] A single-dose, randomized, open-label, two-sequence, two-period, double-crossover bioequivalence study of eltrombopag ethanolamine dry suspension in healthy volunteers under fasting and fed conditions
主要研究目的:以Novartis Pharmaceuticals Corporation持证的艾曲泊帕乙醇胺干混悬剂(商品名:Promacta Kit)为参比制剂,以山东则正医药技术有限公司研发的艾曲泊帕乙醇胺干混悬剂为受试制剂,通过单中心、开放、随机、单剂量、两序列、两周期双交叉临床研究来评价两种制剂的人体生物等效性。
次要研究目的:初步评价受试制剂和参比制剂在健康受试者中的安全性。
[Translation] The main purpose of the study is to use the eltrombopag ethanolamine dry suspension (trade name: Promacta Kit) licensed by Novartis Pharmaceuticals Corporation as the reference preparation and the eltrombopag ethanolamine dry suspension developed by Shandong Zezheng Pharmaceutical Technology Co., Ltd. as the test preparation to evaluate the human bioequivalence of the two preparations through a single-center, open, randomized, single-dose, two-sequence, two-cycle double-crossover clinical study.
Secondary purpose of the study: Preliminary evaluation of the safety of the test preparation and the reference preparation in healthy subjects.