[Translation] A randomized, open-label, single-dose, four-period, completely repeated crossover, fasting bioequivalence study of nitroglycerin tablets in healthy subjects
主要目的:空腹给药条件下,以北京益民药业有限公司生产的硝酸甘油片(规格:0.6 mg)为受试制剂,与Pfizer Inc.生产的硝酸甘油舌下片(参比制剂,商品名:耐较咛®,规格:0.6 mg)对比在健康人体内的药代动力学特征,考察两制剂的人体生物等效性。
次要目的:观察受试制剂硝酸甘油片和参比制剂硝酸甘油舌下片(商品名:耐较咛®)在健康受试者中的安全性。
[Translation] Primary objective: To compare the pharmacokinetic characteristics of nitroglycerin tablets (specification: 0.6 mg) produced by Beijing Yimin Pharmaceutical Co., Ltd. and nitroglycerin sublingual tablets (reference preparation, trade name: Naijiaoning®, specification: 0.6 mg) produced by Pfizer Inc. in healthy subjects under fasting conditions, and to investigate the bioequivalence of the two preparations.
Secondary objective: To observe the safety of the test preparation nitroglycerin tablets and the reference preparation nitroglycerin sublingual tablets (trade name: Naijiaoning®) in healthy subjects.