[Translation] A single-dose oral, randomized, open, double-cycle, double-crossover human bioequivalence study of Diltiazem hydrochloride tablets in healthy volunteers with fasting and after meals
(1)通过盐酸地尔硫卓片空腹和餐后给药的生物等效性研究,评价新华制药(高密)有限公司生产的盐酸地尔硫卓片与田辺三菱製薬生产的盐酸地尔硫卓片的生物等效性,为新华制药(高密)有限公司生产的盐酸地尔硫卓片与原研盐酸地尔硫卓片临床疗效的一致性提供证据。
(2)对盐酸地尔硫卓片的安全性进行评价。
[Translation] (1) Through the bioequivalence study of Diltiazem Hydrochloride Tablets administered on an empty stomach and after meals, the bioequivalence of Diltiazem Hydrochloride Tablets produced by Xinhua Pharmaceutical (Gaomi) Co., Ltd. and Diltiazem Hydrochloride Tablets produced by Tanabe Mitsubishi Co. Provide evidence for the consistency of clinical efficacy between Diltiazem Hydrochloride Tablets produced by Pharmaceutical (Gaomi) Co., Ltd. and original Diltiazem Hydrochloride Tablets.
(2) To evaluate the safety of diltiazem hydrochloride tablets.