Who is sponsoring NCT03355014?

NCT03355014 is sponsored by LG Chem.

What drugs are being tested in NCT03355014?

Interventions in NCT03355014: Combination of gemigliptin/metformin HCl sustained release 50/1000mg, Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg.

What condition does NCT03355014 study?

NCT03355014 studies Healthy Male Volunteers.

Is NCT03355014 still recruiting?

NCT03355014 is currently completed. Last updated 22 February 2018.

Last reviewed 2018-02-22 · How we verify

NCT03355014

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 22 February 2018

What this trial tests

Phase 1 trial testing Combination of gemigliptin/metformin HCl sustained release 50/1000mg in Healthy Male Volunteers in 70 participants. Completed in 12 January 2018.

Timeline

13 December 2017

Primary endpoint
12 January 2018

12 January 2018

Quick facts

Lead sponsor	LG Chem
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	70
Start date	13 December 2017
Primary completion	12 January 2018
Estimated completion	12 January 2018
Sites	1 location across South Korea

Drugs / interventions tested

Combination of gemigliptin/metformin HCl sustained release 50/1000mg — full drug profile →
Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg — full drug profile →

Conditions studied

Healthy Male Volunteers — all drugs for Healthy Male Volunteers →

Sponsor

LG Chem — full company profile →

Who can join

Adults 19 to 45, male only, with Healthy Male Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

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.
Jin X, Kim E, Huh KY, Hwang I, et al · · 2020 · cited 1× · PMID 32274380 · DOI 10.12793/tcp.2020.28.e2

Verify or expand the search:

Other recruiting trials for Healthy Male Volunteers

Currently open trials in the same condition.

NCT07479745 — Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]GRT6019 · Phase 1 · recruiting

Other LG Chem trials

Trials by the same sponsor.

NCT07396844 — The Food Effect on Pharmacokinetics of Fixed Dose Combination of Gemigliptin/Dapagliflozin/Metformin in Healthy Voluntee · Phase 1 · not yet recruiting
NCT07399470 — A Clinical Study in Healthy Adults to See How the Body Processes and How Safe a Tablet That Combines Gemigliptin, Dapagl · Phase 1 · active not recruiting
NCT07333742 — A Clinical Study to See How the Body Handles and How Safe a Combination Tablet of Gemigliptin, Dapagliflozin, and Metfor · Phase 1 · completed
NCT06921395 — Phase IV Study to Evaluate the Efficacy and Safety of Fang Le Shu Compared to Guo Na Fen for Controlled Ovarian Stimulat · Phase 4 · recruiting
NCT06743997 — A Study to Compare Eutropin Formulations in Healthy Volunteers for Bioavailability, Safety, and Tolerability · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03355014 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by LG Chem
Last refreshed: 22 February 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03355014.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing