/ CompletedNot Applicable 吲达帕胺缓释片在健康受试者中的随机、开放、两周期、双交叉空腹及餐后生物等效性预试验
[Translation] A randomized, open-label, two-period, double-crossover pilot study of the fasting and fed bioequivalence of indapamide sustained-release tablets in healthy subjects
主要目的:考察空腹及餐后条件下,初步评价吉林天衡英睿制药有限公司研制的吲达帕胺缓释片(规格:1.5mg)与施维雅(天津)制药有限公司持证的吲达帕胺缓释片(商品名:纳催离,规格:1.5mg)在中国健康受试者中的人体生物等效性,为正式试验的方案设计提供依据。
次要目的:评价吲达帕胺缓释片受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: To investigate the human bioequivalence of indapamide sustained-release tablets (specification: 1.5 mg) developed by Jilin Tianheng Yingrui Pharmaceutical Co., Ltd. and indapamide sustained-release tablets (trade name: Nacuili, specification: 1.5 mg) certified by Servier (Tianjin) Pharmaceutical Co., Ltd. in healthy Chinese subjects under fasting and postprandial conditions, and to provide a basis for the design of the formal trial.
Secondary purpose: To evaluate the safety of the test and reference preparations of indapamide sustained-release tablets in healthy subjects.
100 Clinical Results associated with Jilin Tianheng Yingrui Pharmaceutical Co., Ltd.
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100 Translational Medicine associated with Jilin Tianheng Yingrui Pharmaceutical Co., Ltd.