A Randomized, Open-label, Single-dose, Two-way Crossover Study to Investigate Food-effect Bioavailability of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) Under Fed and Fasting Conditions in Healthy Volunteers

A randomized, open-label, single oral dose, one-treatment, two-period, two-sequence, crossover bioavailability study under fed and fasting conditions in healthy Thai volunteers with at least 7 days washout period between the administrations of investigational products of two consecutive periods.
A: Fixed dose combination Zemimet® SR Tab. 50/1000 mg orally administered once without food (fasting conditions) B: Fixed dose combination Zemimet® SR Tab. 50/1000 mg orally administered once with food (fed conditions)

Start Date01 Nov 2019

Sponsor / Collaborator

LG Chem Ltd.

NCT03355014

/ CompletedPhase 1

A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of the Fixed-dose Combinations of Gemigliptin/Metformin HCl Sustained Release 50/1000 mg (25/500 mg x 2 Tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 1000 mg (500mg x 2 Tablets) Under Fasting and Fed Conditions in Healthy Male Volunteers

This study is to compare the safety/tolerability and pharmacokinetics/pharmacodynamics of the fixed-dose combinations of gemigliptin/metformin HCl sustained release 50/1000 mg (25/500 mg x 2 tablets) in comparison to each component gemigliptin 50 mg and metformin HCl extended release 1000 mg (500mg x 2 tablets) under fasting and fed conditions in healthy male volunteers.

Start Date13 Dec 2017

Sponsor / Collaborator

LG Chem Ltd.

NCT02609815

/ CompletedNot ApplicableIIT

Effect of INitial Combination Therapy With GEmigliptin and Metformin on Microbiota Change and Glycemic Control in patientS With Type 2 DIabetes aNd ObEsity (INTESTINE Study)

The purpose of this study is to investigate gut microbiota change and glucose lowering effect of initial combination therapy of gemigliptin and metformin compared to glimepiride and metformin in obese patients with type 2 diabetes.

Start Date01 Nov 2015

Sponsor / Collaborator

Seoul National University Bundang Hospital

100 Clinical Results associated with Gemigliptin L-tartrate Sesquihydrate/Metformin Hydrochloride

100 Translational Medicine associated with Gemigliptin L-tartrate Sesquihydrate/Metformin Hydrochloride

100 Patents (Medical) associated with Gemigliptin L-tartrate Sesquihydrate/Metformin Hydrochloride

100 Deals associated with Gemigliptin L-tartrate Sesquihydrate/Metformin Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	A10BD18	-

R&D Status

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	South Korea	LG Life Sciences Ltd.	25 Jul 2013

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