A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interactions and Safety After Oral Administration of D745, D150 and CKD-501 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Cmax,ss of CKD-501, D745, D150
研究概览
简要总结
A Clinical trial to investigate the pharmacokinetic drug interaction and safety of CKD-501, D745 and D150
详细描述
A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interactions and Safety after Oral Administration of D745, D150 and CKD-501 in Healthy Adults
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-year-old
- •Weight ≥ 55kg (men) or ≥ 50kg (women), with calculated body mass index(BMI) of 18.5 to 27.0 kg/m2
- •Women must meet one of the criteria written below:
- •Menopause (No menstruation for 2 years)
- •Sterilization (Hysterectomy or Oophorectomy, Tubal ligation etc.)
- •Men agree to contraception & won't donate sperm during the participation of clinical trial
- •Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial
排除标准
- •Those who have clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Digestive system disorder, Endocrine system disorder, Cardiovascular disorder, Blood tumor, Psychical disorder, Severe urinary tract infection
- •Those who have clinically significant dehydration or vulnerable to dehydration by poor oral intake
- •Those who receive intravenous administration of radioactive iodine contrast agents (for intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) within 48 hours before the first administration of investigational product
- •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 below
- •AST, ALT > 1.25 times higher than upper normal level
- •Total bilirubin > 1.5 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, RPR
- •Under 5 min resting condition, systolic blood pressure >150 mmHg or <90 mmHg, diastolic blood pressure >100 mmHg or <50 mmHg
- •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 1
Period 1: CKD-501 - A single oral dose of 1 tablet under fasting conditions for 5 days.
Period 2: CKD-501, D745, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D745: 1 tablet, D150: 2 tablets).
干预措施: CKD-501 (Drug)
Sequence 1
Period 1: CKD-501 - A single oral dose of 1 tablet under fasting conditions for 5 days.
Period 2: CKD-501, D745, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D745: 1 tablet, D150: 2 tablets).
干预措施: CKD-501, D745, D150 (Drug)
Sequence 2
Period 1: CKD-501, D745, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D745: 1 tablet, D150: 2 tablets). Period 2: CKD-501 - A single oral dose of 1 tablet under fasting conditions for 5 days
干预措施: CKD-501 (Drug)
Sequence 2
Period 1: CKD-501, D745, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D745: 1 tablet, D150: 2 tablets). Period 2: CKD-501 - A single oral dose of 1 tablet under fasting conditions for 5 days
干预措施: CKD-501, D745, D150 (Drug)
Sequence 3
Period 1: D745, D150 - A single oral dose of 3 tablets under fasting conditions for 5 days (D745: 1 tablet, D150: 2 tablets). Period 2: CKD-501, D745, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D745: 1 tablet, D150: 2 tablets).
干预措施: D745, D150 (Drug)
Sequence 3
Period 1: D745, D150 - A single oral dose of 3 tablets under fasting conditions for 5 days (D745: 1 tablet, D150: 2 tablets). Period 2: CKD-501, D745, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D745: 1 tablet, D150: 2 tablets).
干预措施: CKD-501, D745, D150 (Drug)
Sequence 4
Period 1: CKD-501, D745, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D745: 1 tablet, D150: 2 tablets). Period 2: D745, D150 - A single oral dose of 3 tablets under fasting conditions for 5 days (D745: 1 tablet, D150: 2 tablets).
干预措施: D745, D150 (Drug)
Sequence 4
Period 1: CKD-501, D745, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D745: 1 tablet, D150: 2 tablets). Period 2: D745, D150 - A single oral dose of 3 tablets under fasting conditions for 5 days (D745: 1 tablet, D150: 2 tablets).
干预措施: CKD-501, D745, D150 (Drug)
结局指标
主要结局
Cmax,ss of CKD-501, D745, D150
时间窗: Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours
Cmax,ss: Maximum concentration of drug in plasma at steady state
AUCtau,ss of CKD-501, D745, D150
时间窗: Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours
AUCtau,ss: Area under the plasma drug concentration-time curve within a dosing interval(τ) at steady state
次要结局
- Cmin,ss of CKD-501, D745, D150(Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours)
- Tmax,ss of CKD-501, D745, D150(Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours)
- CLss/F of CKD-501, D745, D150(Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours)
- Fluctuation of CKD-501, D745, D150(Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours)