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To evaluate and compare PK/PD, safety and tolerability of monolayer combination of Gemigliptin/Rosuvastatin 50/20mg and bilayer combination of Gemigliprin/Rosuvastatin 50/20mg in healthy adults.
To evaluate and compare Pharmacokinetics/Pharmacodynamics, safety and tolerability of monolayer combination of Gemigliptin/Rosuvastatin 50/20mg in comparison to bilayer combination of Gemigliprin/Rosuvastatin 50/20mg administered in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| monolayer group | Active Comparator | monolayer of Gemigliptin/Rosuvastatin |
|
| bilayer group | Experimental | bilayer of Gemigliptin/Rosuvastatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monolayer group | Drug | Monolayered combination of gemigliptin and rosuvastatin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gemigliptin AUC | Gemigliptin | 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour |
| Rosuvastain AUC | Rosuvastain | 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour |
| Rosuvastain Cmax | Rosuvastain | 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour |
| Gemigliptin Cmax | Gemigliptin | 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour |
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Inclusion Criteria:
Age: 19~45
Body weight: 55kg or higher(female: 50kg or higher) and BMI 18~27kg/m2
SBP 90~150mmHg, DBP 60-95mmHg
Fasting glucose 70~120mg/dL
Infertility
Barrier methods: Condom, Diaphragm, Cervical cap (Pessary), Spermicide
Hormonal methods: Pills, Injection (Depot), Skin patch, Hormonal implant (Implanon), Vaginal ring
Intrauterine Devices (IUDs): Cooper IUD (Loop), Hormonal IUD (Mirena)
Natural methods: Basic body temperature, Ovulation period, Coitus interruptus, Abstinent
People who perfectly understood clinical trial and independently decided to participate in clinical trial.
People who will be able to collect blood sample during clinical trial period.
People who are suitable to participate clinical trial by physical examination, lab test and medical examination by interview.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| songyi Park | Contact | +82-2-6987-4195 | songyi-park@lgchem.com | |
| hyejin Yoon | Contact | +82-2-6987-4155 | lgclinical@lgchem.com |
| Name | Affiliation | Role |
|---|---|---|
| kyungsang Yoo | Seoul National University Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Bilayer group | Drug | Bilayered combination of gemigliptin and rosuvastatin |
|
| D004700 | Endocrine System Diseases |
| D052439 | Lipid Metabolism Disorders |