A Clinical Trial to Evaluate the Pharmacokinetic Profiles and Safety of CKD-383.

Exclusion Criteria

• •1. Those who have a clinically significant disease or medical history of hepatic-biliary system issues, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Digestive system disorder, Endocrine system disorder, Cardiovascular disorder, Blood tumor and/or mental health problems.
• •2. Those who have signs and symptoms of clinically significant dehydration or who are vulnerable to dehydration by poor oral intake.
• •3. Those who receive intravenous administration of radioactive iodine contrast agents (for Urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) within 48hours before the first administration of investigational product.
• •4. Those who have severe urinary tract infection or have a past medical history of it.
• •5. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
• •6. Those who have past medical history of gastrointestinal disorder(Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of drug
• •7. Those who have history of hypersensitivity to active pharmaceutical ingredient(Lobeglitazone, Empagliflozin, Metformin) or additives.
• •8. Those who have the test results written in below:
• •* AST/ALT \> 1.25 times higher than upper normal level
• •* eGFR(estimated Glomerular Filtration Rate, which is calculated by MDRD) \< 60 mL/min/1.73m2
• •* "positive" or "reactive" test result of Hepatitis B \& C, HIV, PRP
• •* Under 5 min resting condition, systolic blood pressure \>150mmHg or \<90mmHg, Diastolic blood pressure \>100mmHg, or \<50mmHg
• •9. Those who have a drug abuse history within one year or positive reaction on urine drug screening test
• •10. Those who received following drugs, which may affect results of clinical trial and safety. Ethical-the-counter (ETC) drugs and herbal medicines within 14 days before the first administration of the investigational drug. Over-the-counter (OTC) drugs, health foods and vitamin preparations within 7 days before the first administration of the investigational product.
• •11. Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of investigational product
• •12. Those who exceeding an alcohol and smoke consumption criteria or can't stop smoking, consuming alcohol and caffeine during hospitalization period (Criteria: Caffeine \> 5 cups/day, Alcohol \> 210 g/week, Smoke \> 10 cigarettes/day)
• •13. Those who took grapefruit before the first administration of investigational product or can't stop taking grapefruit during hospitalization period
• •14. Those who received investigational product by participating in other clinical trial within 6 months before the first administration of investigational product
• •15. Those who donated whole blood within 2 months or apheresis within 1 month
• •16. Those who received transfusion within 1 month
• •17. Those who are pregnant or breastfeeding
• •18. Those who are deemed inappropriate to participate in clinical trial by investigators