Healthy
Conditions
Brief summary
The objective of the study was to investigate the drug-drug interaction between LC15-0444 and metformin by comparing the pharmacokinetic/pharmacodynamic, safety, tolerability in healthy male subjets after oral administration concomitantly and each alone.
Interventions
DRUGLC15-0444
LC15-0444 50mg qd (8 days once daily)
DRUGMetformin
Metformin 1000 mg bid (8 days twice daily)
DRUGLC15-0444+Metformin
LC15-0444 50mg qd (8 days once daily) + Metformin 1000 mg bid (8 days twice daily)
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 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCτ,ss | up to 171h30m | To confirm and evaluate the pharmacokinetic characters of main metabolites of LC15-0444 |
| Cmax,ss | up to 171h 30m | To confirm and evaluate the pharmacokinetic characters of main metabolites of LC15-0444 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vital signs | up to 171h30m | to measure Safety and tolerability of the investigational products |
| AUECτ,ss | up to 171h30m | Compare the pharmacodynamic interaction between LC15-0444 and metformin in healthy male subjects This parameter is been used to measure DPP4 activity |
| AUEC | up to 171h30m | Compare the pharmacodynamic interaction between LC15-0444 and metformin in healthy male subjects This parameter is been used to measure Active/total GLP-1, glucose, insulin, c-peptide, glucagon. |
Countries
South Korea
Outcome results
None listed