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

NCT02056600 ↗

Phase 1 Completed 24 enrolled LG Life Sciences

RandomizedCrossoverOpen-label

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.

Timeline

Start: 2014-03
Primary completion: 2014-04
Completion: 2014-05

Publications

Cho YS, Lee SH, Lim HS, Bae KS. Pharmacokinetic Equivalence of the High Dose Strength Fixed-Dose Combination Tablet of Gemigliptin/Metformin Sustained Release (SR) and Individual Component Gemigliptin and Metformin XR Tablets in Healthy Subjects. J Korean Med Sci. 2018 Sep 5;33(41):e258. doi: 10.3346/jkms.2018.33.e258. eCollection 2018 Oct 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gemigliptin	Small molecule	50 mg	—
Subject	Metformin	Small molecule	1000 mg	—

Indications

No indication recorded.