Chongqing Ruien Pharmaceutical Co., Ltd.

The main purpose of the study: The trazodone hydrochloride sustained-release tablets (specification: 150 mg) held by Chongqing Ruien Pharmaceutical Co., Ltd. were used as the test preparation (T), and the trazodone hydrochloride sustained-release tablets (specification: 150 mg, trade name: TRITTICO®) certified by AZ. CHIM.RIUN. ANGELINI FRANCESCO ACRAF S.P.A. were used as the reference preparation (R) for bioequivalence testing according to the relevant provisions of bioequivalence testing. Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation trazodone hydrochloride sustained-release tablets (150 mg) in healthy subjects.

The dopamine tablets (specification: 0.25 g) developed by Chongqing Ruien Pharmaceutical Co., Ltd. were used as the test preparation, and the dopamine tablets (trade name: Madopar®, specification: 0.25 g) produced by Shanghai Roche Pharmaceuticals Co., Ltd. were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after a single dose in the postprandial state were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

The dopamine tablets (specification: 0.25 g) developed by Chongqing Ruien Pharmaceutical Co., Ltd. were used as the test preparation, and the dopamine tablets (trade name: Madopar®, specification: 0.25 g) produced by Shanghai Roche Pharmaceuticals Co., Ltd. were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations were investigated after single administration in the fasting and postprandial states to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.