[Translation] A randomized, open-label, two-drug, two-cycle, crossover, postprandial bioequivalence trial of Gliquidone tablets in healthy humans
主要目的:考察餐后状态下单次口服受试制剂格列喹酮片(天津药物研究院药业有限责任公司提供)与参比制剂格列喹酮片(商品名:Glurenorm®,Glenwood GmbH Pharmazeutische Erzeugnisse持证)在健康受试者体内的药代动力学特征,评价餐后状态下口服两种制剂的生物等效性。次要目的:考察受试制剂格列喹酮片和参比制剂格列喹酮片(Glurenorm®)在健康受试者中的安全性。
[Translation] Main purpose: To investigate a single oral dose of the test preparation Gliquidone Tablets (provided by Tianjin Pharmaceutical Research Institute Pharmaceutical Co., Ltd.) and the reference preparation Gliquidone Tablets (trade name: Glurenorm®, Glenwood GmbH Pharmazeutische) in the postprandial state Erzeugnisse license) pharmacokinetic profile in healthy subjects to evaluate the bioequivalence of two oral formulations in the fed state. Secondary objective: To investigate the safety of the test preparation Gliquidone Tablets and the reference preparation Gliquidone Tablets (Glurenorm®) in healthy subjects.