[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.

NCT02395237 / WithdrawnPhase 1IIT

An Open-label, Randomized, Two-treatment Crossover Bioequivalence Study Comparing Two Batches of the Same Fixed Dose Combinations Amaryl® M IR 2/1000 (Glimepiride/Metformin Hydrochloride Immediate Release Combination Tablet) in Fed Conditions in Healthy Male and/or Female Subjects.

The purpose of this study is to assess, after single oral administration under fed conditions, the bioequivalence between the two batches of the same glimepiride/metformin hydrochloride (HCl) 2 mg/1000 mg fixed dose combination (FDC) tablets (immediate release combination tablet Amaryl® M IR 2/1000) manufactured in India and in Turkey.

Start Date01 May 2015

Sponsor / Collaborator

Pharmaceutical Research Unit, Jordan

[+1]

NCT01890629 / CompletedPhase 4

A Multicenter, Randomized, Active-controlled, Parallel Group, Open-label, Exploratory Study to Evaluate the Efficacy on Glucose Variability(MAGE, Glucose SD) and Safety of Initial Combination Therapy of Gemigliptin 50mg q.d., Versus Sitagliptin 100mg q.d., or Glimepiride 2mg q.d. With Metformin 500-1,000mg q.d. in Patients With Type 2 Diabetes

To compare efficacy and safety of initial combination therapy of Gemigliptin versus Sitagliptin or Glimepiride with Metformin on Glucose Variability(MAGE, Glucose SD) in Patients With Type 2 Diabetes Mellitus.

Start Date01 May 2013

Sponsor / Collaborator

LG Life Sciences Ltd.

100 Clinical Results associated with KATP channels x SUR x PRKAB1

100 Translational Medicine associated with KATP channels x SUR x PRKAB1

0 Patents (Medical) associated with KATP channels x SUR x PRKAB1

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