Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-378 and Co-administration of D745, D150, D029 in Healthy Adults (CKD-378)
Type II Diabetes
About this trial
This is an interventional treatment trial for Type II Diabetes
Eligibility Criteria
Inclusion Criteria: Healthy adult aged between 19 to 55 at screening Weight ≥ 50kg(man) or 50kg(woman) Body mass index (BMI) of 18.5 to 27.0kg/m2 If female, one of following conditions. Menopause (no menstruation more than 2 years) or surgically sterilized. Those who agree to contraception from the first Investigational Product (IP) dosing day till 28days after the last dosing day and decide not to provide sperm during the participation of clinical trial Those who voluntarily decide to participate in paper and agree to comply with the cautions after fully understand the detailed description of this clinical trial Exclusion Criteria: Those who have clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Haematooncology disorder, Cardiovascular disorder or Psychical disorder. Those who are vulnerable to dehydration due to lack of ability in oral intake or have dehydration. Those who had medical examination requiring radioactive iodine contrast material injected through IV 48 hours prior to first IP administration. Those who have significant disease or medical history of urinary infection. Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery which can interfere with drug absorption. Those who have hypersensitivity to the main constituents or components of the investigational drug such as empagliflozin, metformin. Those who have tested inappropriate in screening test 28 days prior to IP administration. Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) > 1.25 times higher than upper normal level Epidermal Growth Factor Receptor (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, rapid plasma reagin test (RPR) Under 5 min resting condition, systolic blood pressure >150 mmHg or or <90 mmHg, diastolic blood pressure >100 mmHg or <50 mmHg. Those who has a drug abuse history within one year or positive reaction on urine drug screening test. Woman who are pregnant or breastfeeding Those who exceed an alcohol, caffeine and cigarette consumption (caffeine> 5 cups/day, alcohol> 210g/week, smoking> 10 cigarettes/day) and not able to stop on smoking, caffeine and alcohol Those who have used following drugs that can interfere with the study or have impact on safety of the subject. Ethical drug (ETC), herbal medicinal preparations within 14 days before the first dosing date Over the counter (OTC), vitamins, health supplement within 7 days before the first dosing date Depot injection or implantation within 30 days before the first dosing date Those who received investigational products or participated in bioequivalence test within 180 days before the first administration of clinical trial drugs Those who donated whole blood within 60 days before the first date of administration and donated ingredients within 30 days Those who have received blood transfusion in 30 days Those who are deemed insufficient to participate in clinical study by investigators
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Sequence 1
Sequence 2
Period 1: D745, D150, D029 - A single oral dose of 3tablets under food intake condition Period 2: CKD-378 (low-dose) - A single oral dose of 1tablet under food intake condition
Period 1: CKD-378 (low-dose) - A single oral dose of 1tablet under food intake condition Period 2: D745, D150, D029 - A single oral dose of 3tablets under food intake condition