Shenzhen Foncoo Pharmaceutical Co. Ltd.

The main purpose of the study is to investigate the pharmacokinetic characteristics of a single oral dose of the test preparation (specification: 10 mg) provided by Shenzhen Pan-Gu Pharmaceutical Co., Ltd. and a single oral dose of the reference preparation (trade name: Brintellix®, specification: 10 mg) certified by H.Lundbeck A/S in healthy subjects under fasting and postprandial conditions, to evaluate the bioequivalence between the two preparations, and to provide a basis for the registration application of the test preparation. The secondary purpose of the study is to observe the safety of a single oral dose of the test preparation (specification: 10 mg) or the reference preparation (trade name: Brintellix®, specification: 10 mg) in healthy subjects under fasting and postprandial conditions.

Primary study objective: To investigate the bioequivalence of trazodone hydrochloride tablets (100 mg) developed by Shenzhen FanGu Pharmaceutical Co., Ltd. and trazodone hydrochloride tablets (100 mg) certified by Aziende Chimiche Riunite Angelini Francesco-A.C.R.A.F.S.P.A. in healthy Chinese subjects under fasting/postprandial conditions. Secondary study objective: To observe the safety of the test preparation trazodone hydrochloride tablets and the reference preparation trazodone hydrochloride tablets in healthy Chinese subjects.

The main purpose of the study was to use the trazodone hydrochloride sustained-release tablets (specification: 150 mg) developed by Shenzhen Pan-Gu Pharmaceutical Co., Ltd. as the test preparation and the trazodone hydrochloride sustained-release tablets (specification: 150 mg, trade name: TRITTICO) certified by Aziende Chimiche Riunite Angelini Francesco-A.C.R.A.F.S.p.A as the reference preparation. According to the relevant provisions of the bioequivalence test, the bioequivalence of the two preparations in healthy Chinese adults was evaluated. Secondary purpose of the study was to evaluate the safety of the test preparation and reference preparation (trade name: TRITTICO) of trazodone hydrochloride sustained-release tablets in healthy subjects.