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

Study Overview
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Brief Summary
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A clinical trial to evaluate the pharmacokinetic profiles and safety of CKD-383.

Detailed Description
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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.

Official Title
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A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-383 and Co-administration of CKD-501, D745, D150 Under Fed Condition in Healthy Adults.

Conditions
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Type2 Diabetes Mellitus

Intervention / Treatment
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* Drug: CKD-501, D745, D150
* Drug: CKD-383


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Peroid 1: CKD-501, D745, D150 -PO Peroid 2: CKD-383- PO | Drug: CKD-501, D745, D150<br>* QD, PO<br>Drug: CKD-383<br>* QD, PO<br>|
| Experimental: Sequence 2<br>Peroid 1: CKD-383- PO Peroid 2: CKD-501, D745, D150 -PO | Drug: CKD-501, D745, D150<br>* QD, PO<br>Drug: CKD-383<br>* QD, PO<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast of CKD-383 | AUClast: Area under the concentration-time curve from time zero to the last measurable concetnration time | 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours) | 
| Cmax of CKD-383 | Cmax: Maximum plasma concentration of the drug | 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of CKD-383 | AUCinf: Area under the concentration-time curve from zero up to infinity | 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours) | 
| Tmax of CKD-383 | Tmax: Time to maximum plasma concentration | 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours) | 
| T1/2 of CKD-383 | T1/2: Terminal elimination half-life | 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours) | 
| Vd/F of CKD-383 | Vd/F: Volume of distribution | 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours) | 
| CL/F of CKD-383 | CL/F: Clearance | 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours) |