Healthy Male Volunteers
Conditions
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) in comparison to each component gemigliptin 50 mg and metformin HCl extended release 1000 mg (500mg x 2 tablets) under fasting and fed conditions in healthy male volunteers.
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 HCl sustained release 50/1000 mg (25/500 mg x 2 tablets) in comparison to each component gemigliptin 50 mg and metformin HCl extended release 1000 mg (500mg x 2 tablets) under fasting condition. Part II is designed 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) in comparison to each component gemigliptin 50 mg and metformin HCl extended release 1000 mg (500mg x 2 tablets) under fed conditions. In total, 70 subjects will be enrolled in this study;Part I: 40, Part II :30 subjects. the study design and arms are the same in both parts.
Interventions
DRUGCombination of gemigliptin/metformin HCl sustained release 50/1000mg
Gemigliptin/Metformin HCl extended release 25/500mg 2tablets
DRUGCoadministration of gemigliptin 50mg and metformin HCl extended release 1000mg
Zemiglo 50mg 1 tablet Glucophage XR 2 tablets
Sponsors
LG Chem
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
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) * 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 criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUClast | up to 48hrs of post-dose(pre-dose, 0.5, 1,1.5,2,3,4,5,6,7,8,10,12,14,24,32,48, post dose at 1d and 8d) | To evaluate AUClast of gemigliptin and metformin |
| Cmax | up to 48hrs of post-dose(pre-dose, 0.5, 1,1.5,2,3,4,5,6,7,8,10,12,14,24,32,48, post dose at 1d and 8d) | To evaluate Cmax of gemigliptin and metformin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUEC | up to 48hrs of post-dose (pre-dose, 0.5, 1,1.5,2,3,4,5,6,7,8,10,12,14,24,32,48, post dose at 1d and 8d) | 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