[Translation] To evaluate the effect of the test preparation Eltrombopag ethanolamine tablets (25 mg) and the reference preparation Eltrombopag ethanolamine tablets (trade name: Riverland®, 25 mg) on healthy adult subjects under fasting and postprandial conditions A single-dose, randomized, open-label, two-period, double-crossover bioequivalence study.
主要研究目的:以Novartis Pharma Schweiz AG持证的艾曲泊帕乙醇胺片(商品名:Revolade(瑞弗兰®),25 mg)为参比制剂,以宁波美舒医药科技有限公司研发的艾曲泊帕乙醇胺片为受试制剂,通过单中心、随机、开放、单次给药、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:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Main research purposes: Eltrombopag ethanolamine tablets (trade name: Revolade, 25 mg) licensed by Novartis Pharma Schweiz AG as the reference preparation, and Eltrombopag developed by Ningbo Meishu Pharmaceutical Technology Co., Ltd. Bopaethanolamine tablets are the test preparations, and the human bioequivalence of the two preparations is evaluated through a single-center, randomized, open-label, single-dose, two-period, double-crossover clinical study.
Secondary research purpose: To observe the safety of the test preparation and the reference preparation in Chinese healthy subjects.