Status:
COMPLETED
BE Study of the Combinations of Gemigliptin/Metformin HCl Extended Release 50/1000mg(25/500mg x 2 Tablets) in Comparison to Each Component Administered Alone
Lead Sponsor:
LG Chem
Conditions:
Healthy Male Volunteers
Eligibility:
MALE
19-45 years
Phase:
PHASE1
Brief Summary
This study is to compare the safety/tolerability and pharmacokinetics/pharmacodynamics of the fixed-dose combinations of gemigliptin/metformin HCl sustained release 50/1000 mg (25/500 mg x 2 tablets) ...
Detailed Description
This study will be conducted in separtes 2 Parts. Part I is designed to compare the safety/tolerability and pharmacokinetics/pharmacodynamics of the fixed-dose combinations of gemigliptin/metformin H...
Eligibility Criteria
Inclusion
- Age between 19 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)
- Subjects who are appropriate to conduct study procedure in the decision of investigator
- 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
- Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, meurology, 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 3months
- 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)
Key Trial Info
Start Date :
December 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2018
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03355014
Start Date
December 13 2017
End Date
January 12 2018
Last Update
February 22 2018
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea