Guangzhou Lianrui Pharmaceutical Co. Ltd.

To investigate the pharmacokinetic characteristics of a single oral dose of mesalazine enteric-coated sustained-release granules [test preparation T, specification: 1.5 g (calculated as mesalazine)] provided by Guangzhou Lianrui Pharmaceutical Co., Ltd. or mesalazine enteric-coated sustained-release granules [reference preparation R, trade name: Salofalk®, specification: 1.5 g (calculated as mesalazine)] certified by Dr. Falk Pharma Gmbh in healthy subjects under fasting and postprandial conditions, evaluate the bioequivalence and safety of the two preparations, and provide a basis for the registration application of the test preparation.

The primary objective was to compare the differences in the extent and rate of absorption of epinastine hydrochloride tablets (20 mg) provided by Guangzhou Lianrui Pharmaceutical Co., Ltd. and epinastine hydrochloride tablets (20 mg, trade name: Alesion ®) produced by Nippon Boehringer Ingelheim Co., Ltd. in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence. The secondary objective was to investigate the safety of the test preparation and the reference preparation in healthy volunteers. The secondary objective was to evaluate the safety of epinastine hydrochloride tablets (20 mg/tablet) provided by Guangzhou Lianrui Pharmaceutical Co., Ltd. under fasting and postprandial administration conditions.

The main purpose of the study is to study the pharmacokinetics of the test preparation, Asartan Potassium Tablets (Specification: 80 mg, produced by Guangzhou Lianrui Pharmaceutical Co., Ltd.) and the reference preparation, Asartan Potassium Tablets (trade name Edabi®, specification: 80 mg; produced by Takeda Ireland Ltd.) in healthy subjects after a single oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. The secondary purpose of the study is to evaluate the safety of the test preparation, Asartan Potassium Tablets (Specification: 80 mg) and the reference preparation, Edabi® (Specification: 80 mg) in healthy subjects.