[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test preparation, gliclazide extended-release tablets (strength: 60 mg), and the reference preparation (Diamericon® extended-release tablets) (strength: 60 mg) in healthy adult participants in the fasting and fed state.
主要试验目的:研究空腹和餐后状态下单次口服受试制剂格列齐特缓释片(规格:60 mg,广州柏赛罗药业有限公司生产)与参比制剂(达美康®缓释片)(规格:60 mg,Les Laboratoires Servier Industrie生产)在健康参与者体内的药代动力学特征,评价空腹和餐后状态口服两种制剂的生物等效性。
次要试验目的:研究受试制剂格列齐特缓释片(规格:60 mg)和参比制剂(达美康®缓释片)(规格:60 mg)在健康参与者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation gliclazide sustained-release tablets (specification: 60 mg, produced by Guangzhou Bosero Pharmaceutical Co., Ltd.) and the reference preparation (Diamecon® sustained-release tablets) (specification: 60 mg, produced by Les Laboratoires Servier Industrie) in healthy participants after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state.
Secondary purpose of the study: to study the safety of the test preparation gliclazide sustained-release tablets (specification: 60 mg) and the reference preparation (Diamecon® sustained-release tablets) (specification: 60 mg) in healthy participants.