Food-Effect Bioavailability Study of FDC(Gemigliptin/Metformin HCl Sustained Release) 50/1000mg(25/500mg x 2tablets)
NCT ID: NCT01747083
Last Updated: 2013-10-24
Study Results
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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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2013-01-31
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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A
FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mgx2tablets))under fasting condition
FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))
B
FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mgx2tablets))under fed condition
FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))
Interventions
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FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))
Eligibility Criteria
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Inclusion Criteria
* 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 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)
20 Years
45 Years
MALE
Yes
Sponsors
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LG Life Sciences
INDUSTRY
Responsible Party
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Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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LG-DMCL003
Identifier Type: -
Identifier Source: org_study_id