[Translation] A single-dose, randomized, open-label, two-dose, two-sequence, four-period, fully repeated crossover bioequivalence study of nitroglycerin spray in healthy Chinese participants
主要研究目的:以德国保时佳大药厂G.Pohl-Boskamp Gmbh&Co.KG持证的硝酸甘油喷雾剂(商品名:保欣宁®)为参比制剂,以山西康宝生物制品股份有限公司生产的硝酸甘油喷雾剂为受试制剂,通过单中心、随机、开放、空腹单次给药、四周期、完全重复交叉的临床研究来评价两种制剂的人体生物等效性。
次要研究目的:评价中国成年健康参与者单次使用受试制剂和参比制剂后的安全性。
[Translation] The primary study objective was to evaluate the bioequivalence of the two formulations in humans using a single-center, randomized, open-label, fasting single-dose, four-period, fully repeated crossover clinical study, using the licensed nitroglycerin spray (trade name: Baoxinning®) from G.Pohl-Boskamp Gmbh & Co.KG as the reference formulation and the nitroglycerin spray produced by Shanxi Kangbao Biological Products Co., Ltd. as the test formulation.
The secondary study objective was to evaluate the safety of the test and reference formulations after single administration in healthy Chinese adult participants.