[Translation] A single-center, open-label, randomized, single-dose, two-period, double-crossover bioequivalence study of isosorbide mononitrate extended-release tablets in Chinese healthy subjects under fasting and fed conditions
主要目的:在空腹及餐后给药条件下,比较上海新亚药业闵行有限公司提供的单硝酸异山梨酯缓释片(规格:40 mg)与Riemser Pharma GmbH持证的单硝酸异山梨酯缓释片(商品名:Ismo® retard,规格:40 mg)在健康成年人群中吸收程度和速度的差异,评价其生物等效性。
次要目的:评价空腹及餐后给药条件下,上海新亚药业闵行有限公司提供的单硝酸异山梨酯缓释片(规格:40 mg)在健康受试者中的安全性。
[Translation] Primary objective: To compare the differences in absorption extent and rate between the isosorbide mononitrate sustained-release tablets (specification: 40 mg) provided by Shanghai Xinya Pharmaceutical Minhang Co., Ltd. and the isosorbide mononitrate sustained-release tablets (trade name: Ismo® retard, specification: 40 mg) certified by Riemser Pharma GmbH in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence.
Secondary objective: To evaluate the safety of the isosorbide mononitrate sustained-release tablets (specification: 40 mg) provided by Shanghai Xinya Pharmaceutical Minhang Co., Ltd. in healthy subjects under fasting and postprandial administration conditions.