[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial), two-formulation, two-sequence, two-period, crossover bioequivalence study of memantine hydrochloride orodisintegrating tablets in healthy Chinese subjects
主要目的:观察中国健康受试者在空腹/餐后状态下单次口服受试制剂盐酸美金刚口崩片(规格:10mg;生产企业:山西同达药业有限公司)和参比制剂盐酸美金刚口崩片(商品名:Memary®;规格:10mg;持证商和生产企业:第一三共株式会社)后的药代动力学特征,评价空腹/餐后状态下两种制剂的生物等效性。
次要目的:观察受试制剂盐酸美金刚口崩片和参比制剂盐酸美金刚口崩片(Memary®)在中国健康受试者中的安全性。
[Translation] Primary objective: To observe the pharmacokinetic characteristics of the test preparation memantine hydrochloride orodisintegrating tablets (specification: 10 mg; manufacturer: Shanxi Tongda Pharmaceutical Co., Ltd.) and the reference preparation memantine hydrochloride orodisintegrating tablets (trade name: Memary®; specification: 10 mg; licensee and manufacturer: Daiichi Sankyo Co., Ltd.) in Chinese healthy subjects after a single oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state.
Secondary objective: To observe the safety of the test preparation memantine hydrochloride orodisintegrating tablets and the reference preparation memantine hydrochloride orodisintegrating tablets (Memary®) in Chinese healthy subjects.