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.
Drug: gemigliptin and metformin HCl extended release
Drug: gemigliptin/metformin HCl extended release
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Locations near you
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Full eligibility criteria for NCT01595880
Ages eligible for Study
20 Years to 45 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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)
All locations for NCT01595880
Korea, Republic of (1)
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
View full eligibility
Tris trial is registered with FDA with number: NCT01595880. The sponsor of the trial is LG Life Sciences and it is looking for 29 volunteers for the current phase.
Official trial title: A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Compare 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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