Status:
COMPLETED
A Clinical Trial to Evaluate the Pharmacokinetic Profiles and Safety of CKD-383.
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Type2 Diabetes Mellitus
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief Summary
A clinical trial to evaluate the pharmacokinetic profiles and safety of CKD-383.
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2021
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04810676
Start Date
April 16 2021
End Date
May 26 2021
Last Update
June 10 2021
Active Locations (1)
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1
Severance Hospital
Seoul, Yonsei-ro, Seodaemun-gu 50-1, South Korea, 03722