Study to Evaluate the Food Effect on Pharmacokinetics Profile and Safety of CKD-393

Exclusion Criteria

• •1. Individuals with medical evidence or clinically significant history of hematological, renal, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic, or immune disease (excluding simple dental histories of dental plaque, impacted tooth, or wisdom tooth, etc.) 1-1) Patients with severe heart failure or who had history of heart failure (New York Heart Association (NYHA) class 1, 2, 3, 4) 1-2) Patients with hepatic failure 1-3) Patients with diabetic ketoacidosis, diabetic coma, or type 1 diabetes mellitus 1-4) Patients with severe infection or trauma, or pre-/post-operative patients 1-5) Patients with edema 1-6) Patients with moderate to severe kidney impairment (eGFR\<60 mL/min/1.73 m2) 1-7) Patients who had acute condition that affects renal function such as dehydration, severe infection, cardiovascular collapse (shock), acute myocardial infarction, or sepsis 1-8) Patients who underwent tests using intravenous radioactive iodine contrast (e.g., intravenous urography, intravenous cholangiography, angiography, contrast enhanced computed tomography, etc.) 1-9) Patients with malnutrition, starvation, asthenia, pituitary insufficiency, or adrenal insufficiency 1-10) Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
• •2. Individuals with a history of gastrointestinal disease (e.g., esophageal achalasia, esophagostenosis, or Crohn's disease) or surgery (excluding simple appendectomy, hernia repair, or tooth extraction) that might affect drug absorption
• •3. Individuals who had following laboratory test results at screening:
• •☞ ALT or AST \> 2x the upper limit of the normal range
• •4. Individuals who had regular alcohol consumption exceeding 210 g /week within 6 months prior to screening (Beer (5%) 250 mL = 10 g, Soju (20%) 50 mL = 8 g, wine (12%) 125 mL = 12 g)
• •5. Individuals who smoked 20 cigarettes or more per day within 6 months prior to screening
• •6. Individuals who had taken any investigational product from other clinical or bioequivalence studies within 6 months prior to the first administration of the investigational product of this study
• •7. Individuals who had following vital signs at screening:
• •☞ Sitting systolic blood pressure \< 90 mmHg or ≥ 160 mmHg or sitting diastolic blood pressure \< 60 mmHg or ≥ 100 mmHg
• •8. Individuals who had serious alcohol or drug abuse history within 1 year prior to the screening
• •9. Individuals who had taken any drug known as a strong inducer or inhibitor of drug metabolizing enzymes within 30 days prior to the first administration of the investigational product
• •10. Individuals who had taken prescribed or over-the-counter medicine within 10 days prior to the first administration of the investigational product
• •11. Individuals who had donated whole blood within 2 months or blood components within 1 month prior to the first administration of the investigational product, or who received transfusion within 1 month prior to the first administration of the investigational product
• •12. Individuals who had severe acute/chronic medical or mental conditions that might increase the risk caused by study participation or administration of the investigational product or might interfere with the interpretation of study results
• •13. Individuals with hypersensitivity or history of allergy to the investigational product as well as main ingredients and components of the investigational product (such as tartrazine and sunset yellow FCF)
• •14. Women who were or might be pregnant and who were breastfeeding
• •15. Individuals who could not consume the high-fat meal provided during the clinical study
• •16. Individuals judged by the investigator as inappropriate to participate in the study