[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study of metformin and glipizide tablets

本试验旨在研究单次空腹和餐后口服北京四环科宝制药有限公司研制、生产的二甲双胍格列吡嗪片（500 mg/2.5 mg）的药代动力学特征；以Teva Pharmaceuticals IND. LTD.生产的二甲双胍格列吡嗪片（500 mg/2.5 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。

[Translation]

This study aims to study the pharmacokinetic characteristics of single fasting and postprandial oral administration of metformin glipizide tablets (500 mg/2.5 mg) developed and produced by Beijing Sihuan Kebao Pharmaceutical Co., Ltd.; using metformin glipizide tablets (500 mg/2.5 mg) produced by Teva Pharmaceuticals IND. LTD. as the reference preparation, compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, and evaluate the bioequivalence of the two preparations in humans.

Start Date06 Jan 2021

Sponsor / Collaborator

Beijing Sihuan Kebao Pharmaceutical Co., Ltd.

CTR20190757 / Completed

格列美脲二甲双胍片在健康受试者中随机、开放、单剂量、两周期、两交叉空腹和餐后状态下的生物等效性研究

[Translation] A randomized, open-label, single-dose, two-period, two-crossover bioequivalence study of glimepiride and metformin tablets in healthy subjects under fasting and fed conditions

主要目的：以法国赛诺菲-万安特公司生产Amaryl®M为参比制剂，对比华中药业生产的格列美脲二甲双胍片（受试制剂），考察健康志愿者单次口服格列美脲二甲双胍片在人体的血药浓度及主要药代动力学参数，并评价其生物等效性。次要目的：观察格列美脲二甲双胍片（受试制剂）和格列美脲二甲双胍片（参比制剂）在健康受试者中的安全性。

[Translation]

Primary objective: To compare Amaryl®M produced by Sanofi-Vanant in France with Glimepiride Metformin Tablets (test preparation) produced by Huazhong Pharmaceutical, to investigate the blood concentration and main pharmacokinetic parameters of Glimepiride Metformin Tablets in healthy volunteers after a single oral administration, and to evaluate their bioequivalence. Secondary objective: To observe the safety of Glimepiride Metformin Tablets (test preparation) and Glimepiride Metformin Tablets (reference preparation) in healthy subjects.

Start Date25 Apr 2019

Sponsor / Collaborator

Hubei Huazhong Pharmaceutical Co. Ltd.

100 Clinical Results associated with SUR x PRKAB1

100 Translational Medicine associated with SUR x PRKAB1

0 Patents (Medical) associated with SUR x PRKAB1

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