[Translation] A randomized, open-label, two-dose, four-period, two-sequence, single-dose, repeated crossover pharmacokinetic and bioequivalence study of Nicorandil tablets in healthy volunteers under the fed state (preliminary study)
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] Primary objective: To study the pharmacokinetics of the test preparation nicorandil tablets 5 mg and the reference preparation nicorandil tablets 5 mg (produced by Chugai Pharmaceutical Co., Ltd., trade name: Sigma®) in healthy volunteers after oral administration in the fed state, and to evaluate the intra-individual variation of the reference preparation and the bioequivalence between the test preparation and the reference preparation when administered in the fed state.
Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.