Clinical Study to Evaluate Pharmacokinetic Profiles and Safety of CKD-387 Under Fasting Condition

This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-387 in healthy volunteers under fasting condition.

Inclusion Criteria:Healthy adults volunteers aged between 19 and 54 years old at the time of screeningIndividuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) < 30.5kg/m2 and men's total body weight ≥ 55 kg, women's total body weight ≥ 45 kg* BMI = Weight(kg)/ Height(m)2Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 yearsIndividuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, urinalysis, viral/bacterial, etc.) and vital signs, ECG etc. performed at screeningIndividuals who signed an informed consent form approved by the IRB of Bumin Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective and contentIndividuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of study drug infusionIndividuals with the ability and willingness to participate the entire study periodExclusion Criteria:Individuals with a medical evidence or a history (excluding a dental history of periodontal surgery, impacted wisdom teeth removal, etc.) of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune diseasesIndividuals with a medical history of gastrointestinal disease (e.g., gullet disease such as esophageal achalasia and esophagostenosis and Crohn's disease) or operations (excluding simple appendectomy, herniotomy or tooth extraction) that may affect drug absorptionIndividuals with the following laboratory test results at screening:- ALT or AST > 2x the upper limit of the normal rangeHistory of regular alcohol consumption exceeding 210 g/week within the 6 months prior to screening (1 drink (250 mL) of beer (5%) = 10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12 g)Individuals who smoked more than 20 cigarettes per day within 6 months or consumed more than 5 cups of caffeine per day prior to first administration of investigational drugsIndividuals who had been administered investigational product(s) from other clinical study or bioequivalence study within the 6 months prior to the first administration of investigational drugsFollowing vital signs results at screening- Sitting systolic blood pressure ≥ 150 mmHg or < 90 mmHg and/or sitting diastolic blood pressure ≥100 mmHg or <50 mmHgIndividuals with a medical history of significant alcohol or drug abuse within one year prior to the screeningIndividuals who had taken any drug(s) known as a strong inducer(s) or inhibitor(s) of drug-metabolizing enzymes within 30 days prior to the first administration of investigational drugsIndividuals who had taken prescription or nonprescription drugs within the 10 days prior to the first administration of investigational drugsIndividuals who donated whole blood within the 8 weeks, or blood components within 2 weeks prior to the first administration of investigational drugsIndividuals with severe acute/chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product(s) administration, or may interfere with the interpretation of study resultsIndividuals with hypersensitivity to investigational products or the investigational products ingredientsPatients with nephropathy (eGFR<60 ml/min/1.73 m2)Acute conditions that can affect renal function such as dehydration, severe infection, cardiovascular collapse (shock), acute myocardial infarction, and sepsisPatients with acute or chronic metabolic acidosis including type 1 diabetes mellitus, lactic acidosis, or diabetic ketoacidosis with or without coma, and patients with a history of ketoacidosisDiabetic precomaPatients undergoing intravenous administration of radioactive iodine contrast material (e.g., intravenous urography, venous cholangiography, angiography, computed tomography using contrast medium, etc.)Patients with congestive heart failure or heart failure who require drug treatment (NYHA class IV)Patients with severe infection or severe traumatic systemic disorderPatients with malnutrition, starvation, weakness, pituitary insufficiency or adrenal insufficiencyPatients with genetic problems such as galactose intolerance, Lap lactase deficiency, or glucose-galactose malabsorptionWomen who are pregnant or may be pregnantIndividuals who were deemed to be inappropriate to participate in the study by the investigator