NCT04050098

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: LG Chem · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Type2 Diabetes

Interventions

Type	Name	Description
DRUG	gemigliptin 50 mg and metformin hydrochloride 1000 mg prolonged release	Zemiglo Tablet 50 mg: Each tablet contains gemigliptin tartrate sesquihydrate, equivalent to 50 mg gemigliptin. Glucophage XR 1000 mg: Each tablet contains metformin hydrochloride 1000 mg (equivalent to 780 mg of metformin base).
DRUG	Gemigliptin tartrate sesquihydrate and metformin	Each tablet contains gemigliptin tartrate sesquihydrate 68.9 mg (equivalent to gemigliptin pure free base 50 mg) and metformin hydrochloride 1000.0 mg.

Timeline

• Start date: 2019-11-01
• Primary completion: 2019-11-30
• Completion: 2019-11-30
• First posted: 2019-08-08
• Last updated: 2019-08-08