硝酸甘油舌下片在中国成年健康受试者中的一项随机、开放、空腹单次给药、两制剂、两序列、四周期重复交叉的生物等效性研究
[Translation] A randomized, open-label, fasting single-dose, two-formulation, two-sequence, four-period repeated crossover bioequivalence study of nitroglycerin sublingual tablets in healthy Chinese adult subjects
主要研究目的:
考察单次舌下含服(空腹)受试制剂硝酸甘油舌下片和参比制剂硝酸甘油舌下片,在中国成年健康受试者体内的药代动力学特征,评估空腹条件下分别舌下含服两种制剂的生物等效性。
次要研究目的:
评价受试制剂和参比制剂单次舌下含服0.6mg(空腹)在中国成年健康受试者中的安全性。
[Translation] Main study objectives:
To investigate the pharmacokinetic characteristics of the test preparation nitroglycerin sublingual tablets and the reference preparation nitroglycerin sublingual tablets in healthy adult Chinese subjects after single sublingual administration (fasting), and to evaluate the bioequivalence of the two preparations taken sublingually under fasting conditions.
Secondary study objectives:
To evaluate the safety of the test preparation and the reference preparation at a single sublingual dose of 0.6 mg (fasting) in healthy adult Chinese subjects.
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