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Bioequivalence Study for Gemigliptin/Metformin 50/1000 mg and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg.

Type2 Diabetes Clinical Trial

Official title:
A Randomized, Open-label, Single-dose, Two-way Crossover Bioequivalence Study of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) and Coadministration of Zemiglo Tablet 50 mg (Gemigliptin 50 mg) and Glucophage XR 1000 mg (Metformin Hydrochloride Prolonged Release 1000 mg) Under Fasting Conditions in Healthy Volunteers

Clinical Trial Summary

[Objectives]Primary: To determine and compare the rate and extent of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (Zemimet® SR Tab. 50/1000 mg) and coadministration of corresponding dose of gemigliptin 50 mg (Zemiglo Tablet 50 mg) and metformin hydrochloride 1000 mg prolonged release (Glucophage XR 1000 mg) as individual tablet in healthy subjects under fasting conditions Secondary: To evaluate safety of test and reference formulations

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04050098
Study type Interventional
Source LG Chem
Contact Eunjoo Cho
Phone +82-2-6987-4284
Email eunjoo.cho@lgchem.com
Status Not yet recruiting
Phase Phase 1
Start date November 1, 2019
Completion date November 30, 2019
View Details
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