[Translation] A single-center, randomized, open-label, single-dose, fasting/fed, two-formulation, two-period, double-crossover bioequivalence study to evaluate the efficacy of trazodone hydrochloride extended-release tablets in healthy adult Chinese subjects
主要研究目的
评价中国健康成年受试者空腹及餐后条件下单次单剂量口服盐酸曲唑酮缓释片受试制剂(规格:150mg,申办者:中曦(福建)药业有限公司)和参比制剂(商品名:TRITTICO®,规格:150mg,持证商:AZ. CHIM.RIUN. ANGELINI FRANCESCO ACRAF S.P.A.)后的药代动力学特点和生物等效性。
次要研究目的
研究盐酸曲唑酮缓释片受试制剂(规格:150mg)和参比制剂(商品名:TRITTICO®,规格:150mg)在中国健康成年受试者中的安全性。
[Translation] Main study objectives
To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of trazodone hydrochloride extended-release tablets (specification: 150 mg, applicant: Zhongxi (Fujian) Pharmaceutical Co., Ltd.) and the reference formulation (trade name: TRITTICO®, specification: 150 mg, licensee: AZ. CHIM.RIUN. ANGELINI FRANCESCO ACRAF S.P.A.) after a single oral dose under fasting and postprandial conditions in healthy Chinese adult subjects.
Secondary study objectives
To study the safety of the test formulation of trazodone hydrochloride extended-release tablets (specification: 150 mg) and the reference formulation (trade name: TRITTICO®, specification: 150 mg) in healthy Chinese adult subjects.