NCT02056600

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, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl Sustained Release 50/1000mg in Comparison to Each Component Gemigliptin 50mg and Metformin HCl Extended Release 1000mg Administered in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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 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 sustained release	Administration of combination of gemigliptin 50mg/metformin HCl sustained release 1000mg, for 1day.

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-04-01
• Completion: 2014-05-01
• First posted: 2014-02-06
• Last updated: 2014-05-08

Locations

1 site across 1 country: South Korea