Healthy
Conditions
Brief summary
A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl Sustained Release 50/2000 mg(25/1000 mg x 2 tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg (1000 mg x 2 tablets) Administered in Healthy Male Volunteers.
Interventions
Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg \* 2 tablets, for 1 day
Administration of combination of gemigliptin 25mg/metformin HCl extended release 1000mg \* 2 tablets, for 1day
Sponsors
LG Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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) * 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 |
|---|---|
| t1/2 of Gemigliptin, Metformin | up to 48h post-dose |
| CL/F of Gemigliptin, Metformin | up to 48h post-dose |
| Vd/F of Gemigliptin, Metformin | up to 48h post-dose |
| AUC0-48h of Gemigliptin metabolite(LC15-0636) | up to 48h post-dose |
| Cmax of Gemigliptin metabolite(LC15-0636) | up to 48h post-dose |
| Tmax of Gemigliptin, Metformin | up to 48h post-dose |
| AUCinf of Gemigliptin metabolite(LC15-0636) | up to 48h post-dose |
| t1/2 of Gemigliptin metabolite(LC15-0636) | up to 48h post-dose |
| CL/F of Gemigliptin metabolite(LC15-0636) | up to 48h post-dose |
| Vd/F of Gemigliptin metabolite(LC15-0636) | up to 48h post-dose |
| metabolic ratio(MR) of Gemigliptin metabolite(LC15-0636) | up to 48h post-dose |
| Tmax of Gemigliptin metabolite(LC15-0636) | up to 48h post-dose |
| AUCinf of Gemigliptin, Metformin | up to 48h post-dose |
Countries
South Korea
Outcome results
None listed