[Translation] A randomized, open-label, single-dose, two-formulation, two-period, two-sequence, crossover design bioequivalence study of indapamide sustained-release tablets in healthy subjects under fasting and fed conditions
主要目的:
评价健康受试者在空腹和餐后状态下口服天津梅花生物医药科技有限公司生产的受试制剂吲达帕胺缓释片(规格:1.5mg)与施维雅(天津)制药有限公司生产的参比制剂吲达帕胺缓释片(商品名:纳催离®,规格1.5mg)后是否具有生物等效性。
次要目的:
观察受试制剂吲达帕胺缓释片与参比制剂吲达帕胺缓释片在健康受试者中的安全性。
[Translation] Primary objective:
To evaluate whether the test preparation indapamide sustained-release tablets (specification: 1.5 mg) produced by Tianjin Meihua Biopharmaceutical Technology Co., Ltd. and the reference preparation indapamide sustained-release tablets (trade name: Natali®, specification 1.5 mg) produced by Servier (Tianjin) Pharmaceutical Co., Ltd. are bioequivalent after oral administration in healthy subjects in fasting and postprandial states.
Secondary objective:
To observe the safety of the test preparation indapamide sustained-release tablets and the reference preparation indapamide sustained-release tablets in healthy subjects.