[Translation] A single-dose, randomized, open-label, two-sequence, four-period, complete repeated crossover, bioequivalence study of lumepirone tosylate capsules (42 mg) in Chinese healthy subjects under fasting and fed conditions
主要研究目的:以荣昌制药(淄博)有限公司生产的甲苯磺酸卢美哌隆胶囊为受试制剂,以Intra-Cellular Therapies Inc.持证的甲苯磺酸卢美哌隆胶囊(商品名:Caplyta®)为参比制剂,通过单中心、随机、开放、单次给药、四周期、完全重复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成年受试者中的安全性。
[Translation] The main purpose of the study is to use Lumiperone Tosylate Capsules produced by Rongchang Pharmaceutical (Zibo) Co., Ltd. as the test preparation and Lumiperone Tosylate Capsules (trade name: Caplyta®) certified by Intra-Cellular Therapies Inc. as the reference preparation to evaluate the bioequivalence of the two preparations in humans through a single-center, randomized, open, single-dose, four-cycle, completely repeated crossover clinical study.
Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy adult subjects in China.