Visum Prius Ltd.

This study examined the oral administration of a single dose of Bripipiprazole orally disintegrating tablets (test preparation, specification: 2 mg) produced by Huayitakang Pharmaceutical Co., Ltd. or Otsuka Pharmaceutical Co., Ltd. under fasting conditions to healthy subjects. Pharmacokinetic characteristics of certified bripipiprazole orally disintegrating tablets (reference preparation, trade name: Rexulti® OD Tablets, strength: 2 mg), to evaluate the bioequivalence and safety of the two preparations, this test preparation Provide basis for registration application.

This study examined the oral administration of a single dose of Bripipiprazole orally disintegrating tablets (test preparation, specification: 2 mg) produced by Huayitaikang Pharmaceutical Co., Ltd. or Otsuka Pharmaceutical Co., Ltd. under postprandial conditions. To evaluate the pharmacokinetic characteristics of the company's certified bripipiprazole orally disintegrating tablets (reference preparation, trade name: Rexulti® OD Tablets, strength: 2 mg), and to evaluate the bioequivalence and safety of the two preparations, this subject Provide basis for preparation registration application

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.