[Translation] A randomized, open-label, two-dose, four-cycle, two-sequence, single-dose, repeated cross-dosing pharmacokinetics and bioequivalence study of nicorandil tablets in healthy humans (pre-trial)
主要目的:研究餐后状态下健康志愿者口服受试制剂尼可地尔片5mg与参比制剂尼可地尔片5mg(中外制药株式会社生产,商品名:喜格迈®)的体内的药代动力学,评价参比制剂的个体内变异及餐后状态给药时受试制剂和参比制剂之间的生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: To study the drug in vivo of the test preparation Nicorandil Tablets 5mg and the reference preparation Nicorandil Tablets 5mg (manufactured by Chugai Pharmaceutical Co., Ltd., trade name: SIGMAI®) in healthy volunteers in the postprandial state. Kinetics, evaluating the intra-individual variation of the reference preparation and the bioequivalence between the test preparation and the reference preparation when administered in the postprandial state.
Secondary objective: To observe the safety of the test product and the reference product in healthy subjects.