[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover, fasting and fed bioequivalence study of trazodone hydrochloride extended-release tablets in healthy study participants
主要研究目的:以福州基石医药科技有限公司持有的盐酸曲唑酮缓释片为受试制剂,以AZ. CHIM.RIUN. ANGELINI FRANCESCO ACRAF S.P.A.持证的盐酸曲唑酮缓释片(商品名:TRITTICO®,规格:150 mg)为参比制剂,通过单中心、随机、开放、单次给药、两制剂、两序列、两周期、双交叉临床研究来评价两种制剂在空腹和餐后条件下的生物等效性。
次要研究目的:观察受试制剂和参比制剂在健康研究参与者中的安全性。
[Translation] The main purpose of the study is to use the trazodone hydrochloride sustained-release tablets owned by Fuzhou Keystone Pharmaceutical Technology Co., Ltd. as the test preparation and the trazodone hydrochloride sustained-release tablets (trade name: TRITTICO®, specification: 150 mg) licensed by AZ. CHIM.RIUN. ANGELINI FRANCESCO ACRAF S.P.A. as the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial conditions through a single-center, randomized, open, single-dose, two-preparation, two-sequence, two-period, double-crossover clinical study.
Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy study participants.