NCT01662674

BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered Alone

A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: LG Life Sciences · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics of the combinations of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison to each component administered in healthy male volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	gemigliptin and metformin HCl extended release	Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg, for 1 day
DRUG	gemigliptin/metformin HCl extended release	Administration of combination of gemigliptin 50mg/metformin HCl extended release 500mg, for 1day.

Timeline

• Start date: 2012-10-01
• Primary completion: 2012-11-01
• Completion: 2013-03-01
• First posted: 2012-08-10
• Last updated: 2015-04-03

Locations

1 site across 1 country: South Korea