NCT02670018

BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 2000mg 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 50/2000 mg(25/1000 mg x 2 Tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg(1000 mg x 2 Tablets) Administered in Healthy Male Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: LG Life Sciences · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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 50/2000 mg(25/1000 mg x 2 tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg (1000 mg x 2 tablets) 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 \* 2 tablets, for 1 day
DRUG	gemigliptin/metformin HCl extended release	Administration of combination of gemigliptin 25mg/metformin HCl extended release 1000mg \* 2 tablets, for 1day

Timeline

• Start date: 2015-08-01
• Primary completion: 2015-12-01
• Completion: 2016-03-01
• First posted: 2016-02-01
• Last updated: 2016-02-02

Locations

1 site across 1 country: South Korea