[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period crossover human bioequivalence study of galantamine hydrobromide tablets in healthy participants in China.
主要研究目的:以重庆星创医药有限公司持有的氢溴酸加兰他敏片(4mg)为受试制剂(T),按有关生物等效性试验的规定,以太陽ファルマ株式会社持证的氢溴酸加兰他敏片(4mg)为参比制剂(R)进行生物等效性试验。
次要研究目的:观察受试制剂和参比制剂氢溴酸加兰他敏片(4mg)在健康试验参与者中的安全性。
[Translation] Primary objective: To conduct a bioequivalence study using galantamine hydrobromide tablets (4mg) manufactured by Chongqing Xingchuang Pharmaceutical Co., Ltd. as the test formulation (T), and galantamine hydrobromide tablets (4mg) manufactured by Taiyo Falma Co., Ltd. as the reference formulation (R), in accordance with relevant bioequivalence study regulations.
Secondary objective: To observe the safety of the test formulation and the reference formulation, galantamine hydrobromide tablets (4mg), in healthy participants.