/ CompletedNot Applicable 富马酸卢帕他定片在中国健康受试者中随机、开放、交叉、空腹及餐后给药条件下的生物等效性试验
[Translation] A randomized, open-label, crossover bioequivalence study of rupatadine fumarate tablets in Chinese healthy subjects under fasting and fed conditions
主要目的:本试验以广州市桐晖药业有限公司研发的富马酸卢帕他定片(生产厂家:湖北唯森制药有限公司、规格:10mg)为受试制剂,以原研单位Laboratorios ERN,S.A.的未进口原研药品富马酸卢帕他定片(商品名:Rupafin、规格:10mg)为参比制剂,评估受试制剂和参比制剂在空腹或餐后条件下的生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: This study uses rupatadine fumarate tablets developed by Guangzhou Tonghui Pharmaceutical Co., Ltd. (manufacturer: Hubei Weisen Pharmaceutical Co., Ltd., specification: 10 mg) as the test preparation and rupatadine fumarate tablets (trade name: Rupafin, specification: 10 mg), a non-imported original drug of the original research unit Laboratorios ERN, S.A., as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation under fasting or postprandial conditions.
Secondary objective: Observe the safety of the test preparation and the reference preparation in healthy subjects.
/ Not yet recruitingNot Applicable 盐酸奥洛他定颗粒在中国健康人中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-sequence, two-period, crossover bioequivalence study of olopatadine hydrochloride granules in healthy Chinese subjects under fasting and postprandial administration conditions.
主要目的
本试验以广州市桐晖药业有限公司提供的盐酸奥洛他定颗粒(规格:2.5mg)为受试制剂,以原研单位協和キリン株式会社生产的盐酸奥洛他定颗粒(商品名:Allelock,规格:0.5%(2.5mg/0.5g))为参比制剂,分别考察空腹和餐后状态下受试制剂与参比制剂在健康试验参与者体内的药代动力学参数,评价两制剂的生物等效性。
次要目的
观察受试制剂和参比制剂在健康试验参与者中的安全性。
[Translation] Primary Objective: This study used olopatadine hydrochloride granules (2.5 mg) provided by Guangzhou Tonghui Pharmaceutical Co., Ltd. as the test formulation and olopatadine hydrochloride granules (trade name: Allelock, 0.5% (2.5 mg/0.5 g)) manufactured by Kyowa Kirin Co., Ltd. as the reference formulation. The pharmacokinetic parameters of the test and reference formulations in healthy participants under fasting and postprandial conditions were investigated to evaluate their bioequivalence.
Secondary Objective: To observe the safety of the test and reference formulations in healthy participants.
100 Clinical Results associated with Guangzhou Tosun Pharmaceutical Co., Ltd.
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