[Translation] A single-center, randomized, open-label, single-dose, two-formulation, four-period, two-sequence, completely repeated crossover, fasting bioequivalence study of sublingual nitroglycerin tablets in Chinese healthy subjects
主要研究目的:本研究为健康受试者空腹状态下,单次口服珠海横琴国研医药科技有限公司研发的受试制剂硝酸甘油舌下片(规格:0. 6mg )或原研单位PfizerPhatmaceuticals LLC 生产的参比制剂硝酸甘油舌下片(商品名: N itrostat规格:0.6mg),考察空腹状态下受试制剂与参比制剂在健康受试者体内的药代动力学参数,评价两制剂的生物等效性。
次要研究目的:考察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main research purpose: This study is to investigate the pharmacokinetic parameters of the test preparation and the reference preparation in healthy subjects under fasting state, and evaluate the bioequivalence of the two preparations.
Secondary research purpose: To investigate the safety of the test preparation and the reference preparation in healthy subjects.