[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-sequence, two-period, two-crossover, postprandial bioequivalence study of trazodone hydrochloride extended-release tablets in healthy trial participants.
主要研究目的:以北京华素制药股份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、双交叉临床试验来评价两种制剂在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试验参与者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of trazodone hydrochloride extended-release tablets (licensed by Beijing Huasu Pharmaceutical Co., Ltd.) under postprandial conditions using trazodone hydrochloride extended-release tablets (trade name: TRITTICO®, strength: 150 mg) certified by AZ. CHIM. RIUN. ANGELINI FRANCESCO ACRAF S.P.A. as the test formulation and trazodone hydrochloride extended-release tablets (licensed by AZ. CHIM. RIUN. ANGELINI FRANCESCO ACRAF S.P.A.) as the reference formulation through a single-center, randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover clinical trial.
Secondary objective: To observe the safety of the test and reference formulations in healthy trial participants.