[Translation] Randomized, open-label, single-dose, two-preparation, two-sequence, two-cycle, double-crossover bioequivalence trial of memantine hydrochloride orally disintegrating tablets (20 mg) 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,选择第一三共株式会社生产的盐酸美金刚口崩片(商品名:Memary®,规格:20mg)为参比制剂,对合肥恩瑞特药业有限公司生产并提供的受试制剂盐酸美金刚口崩片(规格:20mg)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盐酸美金刚口崩片(规格:20mg)和参比制剂盐酸美金刚口崩片(商品名:Memary®,规格:20mg)的安全性。
[Translation] Main research purpose: According to the regulations on bioequivalence testing, memantine hydrochloride orally disintegrating tablets (trade name: Memory®, specification: 20mg) produced by Daiichi Sankyo Co., Ltd. was selected as the reference preparation. Hefei Enruite The test preparation memantine hydrochloride orally disintegrating tablets (specification: 20 mg) produced and provided by Pharmaceutical Co., Ltd. were subjected to fasting and postprandial administration human bioequivalence tests to compare the absorption speed and extent of the drug in the test preparation with the participants. Whether the difference between the specific preparations is within the acceptable range, evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary research purpose: To observe the safety of the test preparation memantine hydrochloride orally disintegrating tablets (specification: 20mg) and the reference preparation memantine hydrochloride orally disintegrating tablets (trade name: Memory®, specification: 20mg) orally administered to healthy volunteers .