Oryza Pharmaceuticals Shenzhen Limited

Main study objectives To investigate the pharmacokinetic characteristics of a single oral administration of 1 bag of mesalazine enteric-coated sustained-release granules [test preparation T, specification: 1.5g (based on mesalazine)] provided by Shenzhen Ruihua Pharmaceutical Technology Co., Ltd. and a single oral administration of 1 bag of mesalazine enteric-coated sustained-release granules [reference preparation R, trade name: Salofalk®, specification: 1.5g (based on mesalazine)] certified by Dr. Falk Pharma Gmbh under the same conditions, evaluate the bioequivalence of the two preparations, and provide a basis for the registration application of the test preparation. Secondary study objectives To observe the safety of a single oral administration of 1.5g of the test preparation mesalazine enteric-coated sustained-release granules [specification: 1.5g (based on mesalazine)] and the reference preparation mesalazine enteric-coated sustained-release granules [trade name: Salofalk®, specification: 1.5g (based on mesalazine)] in healthy subjects under fasting and postprandial conditions.