吲达帕胺片健康成年受试者单剂量空腹状态口服给药的单中心、随机、开放、两周期、双交叉生物等效性临床试验
[Translation] A single-center, randomized, open-label, two-period, double-crossover bioequivalence clinical trial of indapamide tablets in healthy adult subjects after single oral administration in the fasting state
主要研究目的:评价中国健康成年受试者单剂量空腹状态下口服受试制剂吲达帕胺片(2.5mg/片,山东绿因药业有限公司生产)与参比制剂吲达帕胺片(商品名:纳催离®,2.5mg/片,Les Laboratoires Servier生产)的生物等效性。次要研究目的:观察受试制剂吲达帕胺片和参比制剂纳催离®在中国健康成年受试者中的安全性。
[Translation] The primary study objective was to evaluate the bioequivalence of the test preparation indapamide tablets (2.5 mg/tablet, produced by Shandong Lvyin Pharmaceutical Co., Ltd.) and the reference preparation indapamide tablets (trade name: Natali®, 2.5 mg/tablet, produced by Les Laboratoires Servier) in Chinese healthy adult subjects after single oral administration under fasting conditions. The secondary study objective was to observe the safety of the test preparation indapamide tablets and the reference preparation Natali® in Chinese healthy adult subjects.
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