硝酸异山梨酯片(5 mg)在健康受试者中的随机、开放、单次给药、四周期、完全重复交叉、空腹及餐后生物等效性试验
[Translation] A randomized, open-label, single-dose, four-period, completely repeated crossover, fasting and fed bioequivalence study of isosorbide dinitrate tablets (5 mg) in healthy subjects
主要研究目的:以天津太平洋制药有限公司研制的硝酸异山梨酯片(规格:5 mg)为受试制剂,Bausch Health US, LLC持证的硝酸异山梨酯片(商品名:ISORDIL®,规格:5 mg)为参比制剂,对比在健康人体内的相对生物利用度,考察两制剂的人体生物等效性。
次要研究目的:观察硝酸异山梨酯片受试制剂和参比制剂(商品名:ISORDIL®)在健康受试者中的安全性。
[Translation] The main purpose of the study is to use the isosorbide dinitrate tablets (specification: 5 mg) developed by Tianjin Pacific Pharmaceutical Co., Ltd. as the test preparation and the isosorbide dinitrate tablets (trade name: ISORDIL®, specification: 5 mg) certified by Bausch Health US, LLC as the reference preparation, to compare the relative bioavailability in healthy humans and investigate the human bioequivalence of the two preparations.
Secondary purpose of the study: to observe the safety of the test preparation and reference preparation of isosorbide dinitrate tablets (trade name: ISORDIL®) in healthy subjects.
硝酸异山梨酯片(5 mg)餐后、随机、开放、三周期、部分重复交叉生物等效性预试验
[Translation] A randomized, open-label, three-period, partially repeated crossover bioequivalence pilot study of isosorbide dinitrate tablets (5 mg) after meals
主要研究目的:以天津太平洋制药有限公司研制的硝酸异山梨酯片(规格:5 mg)为受试制剂(T),以Bausch Health US, LLC生产的硝酸异山梨酯片(商品名:ISORDIL®,规格:5 mg)为参比制剂(R),比较健康受试者在高脂餐后条件下单次口服受试制剂或参比制剂后的药代动力学特征,计算主要药动学参数,初步评价两制剂的生物等效性,为正式试验的设计提供参考。
次要研究目的:观察硝酸异山梨酯片受试制剂和参比制剂在健康受试者中的安全性。
[Translation] The main purpose of the study is to use isosorbide dinitrate tablets (specification: 5 mg) developed by Tianjin Pacific Pharmaceutical Co., Ltd. as the test preparation (T) and isosorbide dinitrate tablets (trade name: ISORDIL®, specification: 5 mg) produced by Bausch Health US, LLC as the reference preparation (R). The pharmacokinetic characteristics of healthy subjects after a single oral administration of the test preparation or the reference preparation under high-fat meal conditions are compared, the main pharmacokinetic parameters are calculated, and the bioequivalence of the two preparations is preliminarily evaluated to provide a reference for the design of the formal trial.
Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation of isosorbide dinitrate tablets in healthy subjects.
100 Clinical Results associated with Tianjin Pacific Pharmaceutical Co., Ltd.
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