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

A phase 1 clinical trial to evaluate pharmacokinetics and safety in healthy adult after oral administration of CKD-383 and co-administration of CKD-501, D745, D150.

Inclusion criteria

• Healthy adult volunteers aged between 19 and 55 years old.
• Weight ≥ 55kg(men) or ≥50kg(women),
• Calculated body mass index(BMI) of 18.5 to 27.0kg/m2

• Body Mass Index(BMI) = Weight(kg) / [Height(m)]2
• Women must meet one of the criteria written in below:

• Menopause (No menstruation for 2 years)
• Sterilization (hysterectomy or Oophorectomy, Tubal ligation etc.)
• Men agree to contraception and not to donate sperm during the participation of clinical trial.
• Those who voluntarily decide to participate and agree to comply with the cautions after fully understand of the detailed description of this clinical trial.

Exclusion criteria

• 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.
• Those who have signs and symptoms of clinically significant dehydration or who are vulnerable to dehydration by poor oral intake.
• 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.
• Those who have severe urinary tract infection or have a past medical history of it.
• Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
• 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
• Those who have history of hypersensitivity to active pharmaceutical ingredient(Lobeglitazone, Empagliflozin, Metformin) or additives.
• 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
• Those who have a drug abuse history within one year or positive reaction on urine drug screening test
• 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.
• Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of investigational product
• 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)
• Those who took grapefruit before the first administration of investigational product or can't stop taking grapefruit during hospitalization period
• Those who received investigational product by participating in other clinical trial within 6 months before the first administration of investigational product
• Those who donated whole blood within 2 months or apheresis within 1 month
• Those who received transfusion within 1 month
• Those who are pregnant or breastfeeding
• Those who are deemed inappropriate to participate in clinical trial by investigators