BE Study of the Combinations of Gemigliptin/Metformin HCl Extended Release 50/1000mg(25/500mg x 2 Tablets) in Comparison to Each Component Administered Alone

Phase 1 Completed 70 enrolled LG Chem

RandomizedCrossoverOpen-labelOther

Summary

This study is to compare the safety/tolerability and pharmacokinetics/pharmacodynamics of the fixed-dose combinations of gemigliptin/metformin HCl sustained release 50/1000 mg (25/500 mg x 2 tablets) in comparison to each component gemigliptin 50 mg and metformin HCl extended release 1000 mg (500mg x 2 tablets) under fasting and fed conditions in healthy male volunteers.

Timeline

Start: 2017-12-13
Primary completion: 2018-01-12
Completion: 2018-01-12

Publications

Jin X, Kim E, Huh KY, Hwang I, Cho JY, Yu KS, Lee S. Pharmacokinetics and pharmacodynamics of a fixed-dose combination of gemigliptin/metformin sustained release 25/500 mg compared to the loose combination in healthy male subjects. Transl Clin Pharmacol. 2020 Mar;28(1):43-54. doi: 10.12793/tcp.2020.28.e2. Epub 2020 Mar 30.

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.