[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of emedastine fumarate extended-release capsules (2 mg) in Chinese healthy subjects under fasting and fed conditions
"主要研究目的:按有关生物等效性试验的规定,选择日本興和株式会社为持证商的富马酸依美斯汀缓释胶囊(商品名:REMICUT;规格:2mg)为参比制剂,对四川德峰药业有限公司生产提供的受试制剂富马酸依美斯汀缓释胶囊(规格:2mg)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:观察中国健康受试者服用受试制剂富马酸依美斯汀缓释胶囊(规格:2mg)和参比制剂富马酸依美斯汀缓释胶囊(商品名:REMICUT;规格:2mg)后的安全性。
[Translation] "Main research purpose: According to the regulations on bioequivalence testing, select emestine fumarate sustained-release capsules (trade name: REMICUT; specification: 2 mg) of Japan Kowa Co., Ltd. as the licensee as the reference preparation , conduct human bioequivalence tests on fasting and postprandial administration of the test preparation emestine fumarate sustained-release capsules (specification: 2 mg) produced and provided by Sichuan Defeng Pharmaceutical Co., Ltd., and compare the drugs in the test preparation Whether the difference in absorption rate and degree of absorption from the reference preparation is within the acceptable range, evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary research purpose: To observe Chinese healthy subjects taking the test preparation emedestine fumarate sustained-release capsules (specification: 2 mg) and the reference preparation emedestine fumarate sustained-release capsules (trade name: REMICUT; Specification: 2mg) after safety.