NCT04810676已完成1 期
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.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Cmax of CKD-383
研究概览
简要总结
A clinical trial to evaluate the pharmacokinetic profiles and safety of CKD-383.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Sequence 2
Experimental
Peroid 1: CKD-383- PO
Peroid 2: CKD-501, D745, D150 -PO
干预措施: CKD-383 (Drug)
Sequence 2
Experimental
Peroid 1: CKD-383- PO
Peroid 2: CKD-501, D745, D150 -PO
干预措施: CKD-501, D745, D150 (Drug)
Sequence 1
Experimental
Peroid 1: CKD-501, D745, D150 -PO
Peroid 2: CKD-383- PO
干预措施: CKD-501, D745, D150 (Drug)
Sequence 1
Experimental
Peroid 1: CKD-501, D745, D150 -PO
Peroid 2: CKD-383- PO
干预措施: CKD-383 (Drug)
结局指标
主要结局
Cmax of CKD-383
时间窗: 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)
Cmax: Maximum plasma concentration of the drug
AUClast of CKD-383
时间窗: 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)
AUClast: Area under the concentration-time curve from time zero to the last measurable concetnration time
次要结局
- CL/F of CKD-383(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(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(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(0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours))
- AUCinf of CKD-383(0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-378 and Co-administration of D745, D150, D029 in Healthy AdultsType II DiabetesNCT05881213Chong Kun Dang Pharmaceutical23
已完成
1 期
A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of CKD-378Type II DiabetesNCT05741437Chong Kun Dang Pharmaceutical24
已完成
1 期
A Study to Investigate the PK and Safety of CKD-393Type II DiabetesNCT04768673Chong Kun Dang Pharmaceutical26
Unknown
1 期
A Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-396Type2 Diabetes MellitusNCT04246190Chong Kun Dang Pharmaceutical26
Unknown
1 期
Clinical Trial to Investigate the Pharmacokinetics and Safety of CKD-393T2DM (Type 2 Diabetes Mellitus)NCT04706286Chong Kun Dang Pharmaceutical26