[Translation] A randomized, open-label, two-dose, two-period, two-sequence, single-dose, double-crossover bioequivalence study of trazodone hydrochloride extended-release tablets in healthy subjects under fasting and fed conditions
主要目的:以健康受试者为试验对象,采用随机、开放、两周期、两序列、双交叉试验设计,考察健康受试者空腹及餐后单次口服华益药业科技(安徽)有限公司生产(九华华源药业(桂林)有限公司持有)的盐酸曲唑酮缓释片(受试制剂,规格:150 mg)与Az.Chim.Riun.Angelini Francesco Acraf S.P.A.生产的盐酸曲唑酮缓释片(参比制剂,商品名:曲特恪®\Trittico®,规格:150 mg)后曲唑酮的体内经时过程,估算其相关药代动力学参数及相对生物利用度,评价其空腹及餐后状态下的生物等效性,为受试制剂的生产注册申请提供依据。
次要目的:评价盐酸曲唑酮缓释片受试制剂和参比制剂(商品名:曲特恪®\Trittico®)在健康受试者中的安全性。
[Translation] Main purpose: With healthy subjects as the test subjects, a randomized, open, two-period, two-sequence, double-crossover design was used to investigate the in vivo time course of trazodone after a single oral administration of trazodone hydrochloride sustained-release tablets (test preparation, specification: 150 mg) produced by Huayi Pharmaceutical Technology (Anhui) Co., Ltd. (held by Jiuhua Huayuan Pharmaceutical (Guilin) Co., Ltd.) and trazodone hydrochloride sustained-release tablets (reference preparation, trade name: Trittico®\Trittico®, specification: 150 mg) produced by Az.Chim.Riun.Angelini Francesco Acraf S.P.A. on fasting and after meals, estimate their relevant pharmacokinetic parameters and relative bioavailability, evaluate their bioequivalence in fasting and after meals, and provide a basis for the production registration application of the test preparation.
Secondary purpose: To evaluate the safety of the test preparation and reference preparation (trade name: Trittico®\Trittico®) of trazodone hydrochloride sustained-release tablets in healthy subjects.