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] Isosorbide Dinitrate Tablets (5 mg) postprandial, randomized, open, three-cycle, partly repeated crossover bioequivalence pilot test
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] Main research purposes: Isosorbide dinitrate tablets (specification: 5 mg) developed by Tianjin Pacific Pharmaceutical Co., Ltd. were used as the test preparation (T), and Isosorbide dinitrate tablets (trade name: ISORDIL® , specification: 5 mg) is the reference preparation (R), compare the pharmacokinetic characteristics of healthy subjects after a single oral administration of the test preparation or the reference preparation under high-fat postprandial conditions, and calculate the main pharmacokinetic parameters , to preliminarily evaluate the bioequivalence of the two preparations, and provide reference for the design of formal trials.
Secondary research purpose: To observe the safety of the test preparation and reference preparation of isosorbide dinitrate tablets in healthy subjects.
100 Clinical Results associated with Tianjin Pacific Pharmaceutical Co., Ltd.
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