[Translation] A single oral, single-center, randomized, open-label, two-period, crossover bioequivalence study of donepezil hydrochloride orally disintegrating tablets
主要目的
观察盐酸多奈哌齐口腔崩解片在中国健康受试者中单次口服给药后多奈哌齐的体内动力学过程,估算相应的药代动力学参数,并以日本卫材株式会社生产的盐酸多奈哌齐口腔崩解片(Aricept® D)为参比制剂,进行生物等效性评价。
次要目的
观察盐酸多奈哌齐口腔崩解片(受试制剂)和Aricept® D(参比制剂)在健康人体中的安全性。
[Translation] Main objective
To observe the in vivo kinetics of donepezil hydrochloride orally disintegrating tablets after a single oral administration in healthy Chinese subjects, estimate the corresponding pharmacokinetic parameters, and evaluate the bioequivalence of donepezil hydrochloride orally disintegrating tablets (Aricept® D) produced by Eisai Co., Ltd. as the reference preparation.
Secondary objective
To observe the safety of donepezil hydrochloride orally disintegrating tablets (test preparation) and Aricept® D (reference preparation) in healthy humans.