NCT01595880

BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg 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 of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (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 of the combinations of gemigliptin 50mg and metformin HCl extended release 500mg in comparison to each component administered alone 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 500mg, 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: 2014-12-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2012-05-10
• Last updated: 2015-02-03

Locations

1 site across 1 country: South Korea