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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

NCT03355014 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2018-02-22

No results posted yet for this study

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.

Conditions

  • Healthy Male Volunteers

Interventions

DRUG

Combination of gemigliptin/metformin HCl sustained release 50/1000mg

Gemigliptin/Metformin HCl extended release 25/500mg 2tablets

DRUG

Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg

Zemiglo 50mg 1 tablet Glucophage XR 2 tablets

Sponsors & Collaborators

  • LG Chem

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03355014 on ClinicalTrials.gov