Xi'an Yuanda Kechuang Pharmaceutical Technology Co., Ltd.

Primary objective: Using the brepazole tablets (trade name: Rexulti, specification: 2mg) of the licensee Otsuka America Pharmaceutical, Inc. as the reference preparation and the brepazole tablets (2mg) developed by Xi'an Yuanda Kechuang Pharmaceutical Technology Co., Ltd. as the test preparation, a single-center, randomized, open, single-dose, two-preparation, two-cycle, two-sequence, crossover clinical trial was conducted to evaluate the bioequivalence of the two preparations in fasting and postprandial states in healthy Chinese subjects. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

The main purpose of the study is to evaluate the pharmacokinetic characteristics of the test formulation of trazodone hydrochloride tablets (specification: 50 mg, holder: Xi'an Yuanda Kechuang Pharmaceutical Technology Co., Ltd.) and the reference formulation (trade name: RESLIN®, specification: 50 mg, licensee: オルガノン Co., Ltd.) after a single oral administration under fasting and postprandial conditions in healthy Chinese subjects, and to investigate whether the two are bioequivalent under fasting and postprandial conditions. Secondary purpose of the study: to evaluate the safety of the test formulation of trazodone hydrochloride tablets (specification: 50 mg) and the reference formulation (trade name: RESLIN®; specification: 50 mg) in healthy subjects.

Perampanel tablets certified by Xi'an Yuanda Kechuang Pharmaceutical Technology Co., Ltd. were used as the test preparation, and Perampanel tablets certified by Eisai Europe Limited were used as the reference preparation to evaluate the relative bioavailability and bioequivalence in humans.