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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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G+M

Coadministration of gemigliptin 50mg and metformin HCl extended release 500mg

Group Type EXPERIMENTAL

gemigliptin and metformin HCl extended release

Intervention Type DRUG

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

C

Combination of gemigliptin50mg/metformin HCl extended release 500mg

Group Type EXPERIMENTAL

gemigliptin/metformin HCl extended release

Intervention Type DRUG

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

Interventions

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gemigliptin and metformin HCl extended release

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

Intervention Type DRUG

gemigliptin/metformin HCl extended release

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age between 20 to 45, healthy male subjects(at screening)
* Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
* FPG 70-125mg/dL glucose level(at screening)
* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria

* Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
* Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
* Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)
* Subject who already participated in other trials in 2months
* Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months currently.
* Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes