/ RecruitingNot 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.
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