[Translation] A single-center, randomized, open-label, single (fasting/after meal) oral administration, two preparations, two sequences, two cycles, crossover human bioequivalence study of memantine hydrochloride orally disintegrating tablets in Chinese healthy subjects test
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] Main purpose: To observe the single oral administration of the test preparation memantine hydrochloride orally disintegrating tablets (specification: 10 mg; manufacturer: Shanxi Tongda Pharmaceutical Co., Ltd.) and the reference preparation memantine hydrochloride in fasting/postprandial conditions in Chinese healthy subjects. Pharmacokinetic characteristics of King Kong orally disintegrating tablets (trade name: Memory®; strength: 10 mg; license holder and manufacturer: Daiichi Sankyo Co., Ltd.), and evaluation of the bioequivalence of the two preparations in the fasting/postprandial state effectiveness.
Secondary purpose: To observe the safety of the test preparation memantine hydrochloride orally disintegrating tablets and the reference preparation memantine hydrochloride orally disintegrating tablets (Memary®) in Chinese healthy subjects.