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

Phase 1 Completed 27 enrolled LG Life Sciences

RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start: 2012-10
Primary completion: 2012-11
Completion: 2013-03

Publications

Park SI, Lee H, Oh J, Lim KS, Jang IJ, Kim JA, Jung JH, Yu KS. A fixed-dose combination tablet of gemigliptin and metformin sustained release has comparable pharmacodynamic, pharmacokinetic, and tolerability profiles to separate tablets in healthy subjects. Drug Des Devel Ther. 2015 Feb 4;9:729-36. doi: 10.2147/DDDT.S75980. eCollection 2015.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gemigliptin	Small molecule	25 mg	Oral
Subject	Gemigliptin	Small molecule	50 mg	Oral
Subject	Metformin	Small molecule	500 mg	Oral
Subject	Metformin	Small molecule	1000 mg	Oral

Indications

No indication recorded.