[Translation] A single-center, randomized, open-label, two-dose, fasting and postprandial, single-dose, two-period, double-crossover bioequivalence study of gliclazide sustained-release tablets developed by Zhejiang Kangde Pharmaceutical Group Co., Ltd. and gliclazide sustained-release tablets (trade name: Diamecon®) produced by Servier (Tianjin) Pharmaceutical Co., Ltd. in healthy adult subjects in China
以浙江康德药业集团股份有限公司研制的格列齐特缓释片(规格:30 mg)为受试制剂,持证商为施维雅(天津)制药有限公司的格列齐特缓释片(商品名:达美康®,规格:30 mg)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性,同时评价两制剂在健康受试者中的安全性
[Translation] Gliclazide sustained-release tablets (specification: 30 mg) developed by Zhejiang Kangde Pharmaceutical Group Co., Ltd. were used as the test preparation, and Gliclazide sustained-release tablets (trade name: Diamecon®, specification: 30 mg) produced by Servier (Tianjin) Pharmaceutical Co., Ltd. were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent, and the safety of the two preparations in healthy subjects was evaluated.