[Translation] A single-dose, randomized, open, double-cycle, double-crossover human bioequivalence study of Diltiazem hydrochloride tablets in healthy volunteers with fasting and postprandial
观察单次口服30mg(空腹/餐后)受试制剂盐酸地尔硫卓片(规格:30mg/片,上海信谊万象药业股份有限公司生产)与参比制剂盐酸地尔硫卓片(HERBESSER,规格:30mg/片,MITSUBISHI TANABE PHARMA CORPORATION生产)在中国成年健康受试者体内的药代动力学特征,评价空腹与餐后状态下分别口服两种制剂的生物等效性。
[Translation] Observe the test preparation Diltiazem Hydrochloride Tablets (specification: 30mg/tablet, produced by Shanghai Xinyi Vientiane Pharmaceutical Co., Ltd.) and the reference preparation Diltiazem Hydrochloride Tablets (HERBESSER, specification: 30mg/tablet) after a single oral administration of 30mg (fasting/after meals). , MITSUBISHI TANABE PHARMA CORPORATION) pharmacokinetics in Chinese adult healthy subjects, and evaluate the bioequivalence of two oral preparations in fasting and postprandial states, respectively.