[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of memantine hydrochloride orodisintegrating tablets (20 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 relevant provisions of bioequivalence test, the memantine hydrochloride orodisintegrating tablets (trade name: Memary®, specification: 20 mg) produced by Daiichi Sankyo Co., Ltd. were selected as the reference preparation, and the test preparation memantine hydrochloride orodisintegrating tablets (specification: 20 mg) produced and provided by Hefei Enrui Pharmaceutical Co., Ltd. were subjected to fasting and postprandial human bioequivalence test, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to 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 memantine hydrochloride orodisintegrating tablets (specification: 20 mg) and the reference preparation memantine hydrochloride orodisintegrating tablets (trade name: Memary®, specification: 20 mg) by healthy volunteers.