[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of olopatadine hydrochloride tablets in Chinese healthy volunteers under fasting and fed conditions
本研究采用随机、开放、单剂量、两周期、双交叉的设计。评价健康受试者在空腹和餐后条件下给药盐酸奥洛他定片受试制剂(晋城海斯制药有限公司,5mg/片)或参比制剂(5mg/片,商品名:Allelock ®)后的吸收速度及吸收程度,考察两制剂的人体生物等效性。同时观察盐酸奥洛他定片在健康人群中的安全性。
[Translation] This study adopted a randomized, open, single-dose, two-period, double-crossover design. The absorption rate and extent of the test formulation of olopatadine hydrochloride tablets (Jincheng Haisi Pharmaceutical Co., Ltd., 5 mg/tablet) or the reference formulation (5 mg/tablet, trade name: Allelock ®) were evaluated in healthy subjects under fasting and postprandial conditions, and the human bioequivalence of the two formulations was investigated. At the same time, the safety of olopatadine hydrochloride tablets in healthy people was observed.