Food-Effect Bioavailability Study of FDC(Gemigliptin/Metformin HCl Sustained Release) 50/1000mg(25/500mg x 2tablets)

October 22, 2013 updated by: LG Life Sciences

A Randomized, Open Label, Single Dose, Crossover Study to Investigate Food-effect Bioavailability of FDC(Gemigliptin/Metformin HCl Sustained Release) 50/1000mg(25/500mg x 2tablets)Under Fed and Fasting Conditions in Healthy Male Volunteers

This study is designed to investigate the food-effects on FDC(gemigliptin/metformin HCl sustained release) 50/1000mg(25/500mg x 2tablets)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age between 20 to 45, healthy male subjects(at screening)
  • BMI between 19.0 - 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 90 days
  • Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently.
  • Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mgx2tablets))under fasting condition
Drug: FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))
EXPERIMENTAL: B
FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mgx2tablets))under fed condition
Drug: FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUClast
Time Frame: up to 48 h post-dose
To evaluate AUClast of gemigliptin and metformin
up to 48 h post-dose
Cmax
Time Frame: up to 48 h post-dose
TO evaluate Cmax of gemigliptin and metformin
up to 48 h post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCinf
Time Frame: up to 48 h post-dose
To evaluate AUCinf of gemigliptin,metformin and LC15-0636(active metabolite of gemigliptin)
up to 48 h post-dose
Tmax
Time Frame: up to 48h post-dose
To evaluate Tmax of gemigliptin, metformin and LC15-0636(active metabolite of gemigliptim)
up to 48h post-dose
t1/2
Time Frame: up to 48 h post-dose
To evaluate t1/2 of gemigliptin, metformin and LC15-0636(active metabolite of gemigliptim)
up to 48 h post-dose
Cmax
Time Frame: up to 48h post-dose
To evaluate Cmax of LC15-0636(active metabolite of gemigliptim)
up to 48h post-dose
AUClast
Time Frame: up to 48h post-dose
To evaluate AUClast of LC15-0636(active metabolite of gemigliptim)
up to 48h post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Life Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

November 30, 2012

First Submitted That Met QC Criteria

December 10, 2012

First Posted (ESTIMATE)

December 11, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 24, 2013

Last Update Submitted That Met QC Criteria

October 22, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-DMCL003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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