[Translation] Randomized, open-label, single-dose, two-sequence, four-cycle, fully replicated crossover bioequivalence trial of mesalazine enteric-coated tablets (0.5g) in Chinese healthy subjects under fasting and postprandial administration conditions
主要研究目的:按有关生物等效性试验的规定,选择Dr. Falk Pharma GmbH为持证商的美沙拉秦肠溶片(商品名:Salofalk;规格:0.5g)为参比制剂,对浙江美迪深生物医药有限公司为持证商并提供的受试制剂美沙拉秦肠溶片(规格:0.5g)进行空腹和餐后给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评价两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的:观察健康志愿受试者口服受试制剂美沙拉秦肠溶片(规格:0.5g)和参比制剂美沙拉秦肠溶片(商品名:Salofalk;规格:0.5g)的安全性。
[Translation] Main research purpose: According to the regulations on bioequivalence testing, mesalazine enteric-coated tablets (trade name: Salofalk; specification: 0.5g) of Dr. Falk Pharma GmbH, which is the licensee, was selected as the reference preparation. Di Shen Biopharmaceutical Co., Ltd. is a licensee and provides the test preparation mesalazine enteric-coated tablets (specification: 0.5g) to conduct fasting and postprandial administration human bioequivalence tests to compare the absorption of the drug in the test preparation Whether the differences in speed and degree of absorption from the reference preparation are within acceptable limits, evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary research purpose: To observe the safety of oral administration of the test preparation mesalazine enteric-coated tablets (specification: 0.5g) and the reference preparation mesalazine enteric-coated tablets (trade name: Salofalk; specification: 0.5g) to healthy volunteers. sex.