Healthy
Conditions
Brief summary
This study is to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics of the combinations of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison to each component administered in healthy male volunteers.
Interventions
Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg, for 1 day
Administration of combination of gemigliptin 50mg/metformin HCl extended release 500mg, for 1day.
Sponsors
LG Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUClast | up to 48h post-dose | To evaluate AUClast of gemigliptin and metformin |
| Cmax | up to 48h post-dose | To evaluate Cmax of gemigliptin and metformin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUEC | up to 48h post-dose | This parameter is been used to measure pharmarcodynamic characters of gemigliptin and metformin, the supression rate of DPP4 activity. |
Countries
South Korea
Outcome results
None listed