/ CompletedNot Applicable 盐酸奥洛他定口服溶液在空腹和餐后条件下的人体生物等效性试验
[Translation] Human bioequivalence studies of olopatadine hydrochloride oral solution under fasting and postprandial conditions.
主要研究目的:本研究以云鹏医药集团有限公司提供的盐酸奥洛他定口服溶液【规格:10ml:5mg】为受试制剂,以原研厂家協和キリン株式会社生产的盐酸奥洛他定颗粒【规格:0.5%(2.5mg/0.5g),商品名:Allelock®】为参比制剂,评价受试制剂和参比制剂在空腹及餐后条件下给药后的生物等效性。
次要研究目的:观察单次口服 5mg 的盐酸奥洛他定口服溶液受试制剂或盐酸奥洛他定颗粒参比制剂在健康研究参与者中的安全性。
[Translation] Primary Objective: This study evaluated the bioequivalence of the test and reference formulations under fasting and postprandial administration conditions using olopatadine hydrochloride oral solution (10ml:5mg) provided by Yunpeng Pharmaceutical Group Co., Ltd., and olopatadine hydrochloride granules (0.5% (2.5mg/0.5g), trade name: Allelock®) manufactured by Kyowa Kirin Co., Ltd., as the reference formulation.
Secondary Objective: To observe the safety of a single oral dose of 5mg olopatadine hydrochloride oral solution (test formulation) or olopatadine hydrochloride granules (reference formulation) in healthy study participants.
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