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BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone

NCT01595880 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2015-02-03

No results posted yet for this study

Summary

This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and metformin HCl extended release 500mg in comparison to each component administered alone in healthy male volunteers.

Conditions

  • Healthy

Interventions

DRUG

gemigliptin and metformin HCl extended release

Coadministration of gemigliptin 50mg and metformin HCl extended release 500mg, for 1 day

DRUG

gemigliptin/metformin HCl extended release

Administration of combination of gemigliptin 50mg/metformin HCl extended release 500mg, for 1day.

Sponsors & Collaborators

  • LG Life Sciences

    lead INDUSTRY

Principal Investigators

  • Kyung-sang Yu, M.D,Ph.D · Seoul national univ. hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-01-31
Completion
2015-01-31

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 NCT01595880 on ClinicalTrials.gov