NCT05113693已完成1 期
A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393 in Healthy Volunteers Under Fed Conditions
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
- 33
- 试验地点
- 1
- 主要终点
- AUCt of CKD-501, D759, H053
研究概览
简要总结
Objective
- Evaluation of the pharmacokinetic properties and safety of CKD-393 0.25/50/750 mg oral administration in healthy adults under fed condition.
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 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers aged 19 ≤ ~ < 55-year-old.
- •Weight ≥55kg (man) or 45kg (woman), with calculated body mass index (BMI) of 17.5 ≤ ~ < 30.5 kg/m
- •Those who have no congenital diseases or chronic diseases within 3 years and have no abnormal symptoms or findings.
- •Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
- •Those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.
- •Those who agree to contraception until the 1 month after last administration of clinical trial drugs.
- •Those who have the ability and willingness to participate during the entire clinical trail.
排除标准
- •Those who have clinically significant disease or medical history of heart failure, Hepatopathy, Type 1 Diabetes, Diabetic ketoacidosis, Edema, Renal dysfunction, galactose intolerance, glucose-galactose malabsorption. And Those who receive intravenous administration of radioactive iodine contrast agents (for intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) during clinical trial.
- •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 investigational drug.
- •Those who have the test results written below
- •AST, ALT > 2 times higher than upper normal level
- •Those who exceeding an alcohol consumption criteria(210g/week) within 6 months before the first administration of investigational drug.
- •Beer 1 glass(250ml, Alcohol contents 5%) = 10g
- •Soju 1 glass(50ml, Alcohol contents 20%) = 8g
- •Wine 1 glass(125ml, Alcohol contents 12%) = 12g
- •Those who exceeding smoking criteria(20 cigarettes/day) within 6 months before the first administration of investigational drug.
- •Those who received investigational durg by participating in other clinical trial within 6 months before the first administration of investigational drug.
- •Those who have vital sign written below
- •systolic blood pressure ≥140 mmHg or < 90 mmHg
- •diastolic blood pressure ≥ 90 mmHg or < 60 mmHg
- •Those who have a drug or alcohol abuse history within 1 year before the first administration of investigational drug.
- •Those who take barbiturate and related (causing induction or inhibition. of metabolism) drug within 30 days before the first administration of investigational drug.
- •Those who received Ethical-the-counter (ETC) drugs or Over-the-counter (OTC) drugs within 10 days before the first administration of investigational drug.
- •Those who donated whole blood within 2 months or apheresis within 1 month before the first administration of investigational drug.
- •Those who severe acute/chronic medical or mental condition which can increase the safety risk by administration of investigational drug.
- •Those who have history of hypersensitivity to active pharmaceutical ingredient or additives.
- •Those who are pregnant or breastfeeding.
- •Those who can't ingest a high fat diet.
- •Those who are deemed inappropriate to participate in clinical trial by investigators.
研究组 & 干预措施
1
Experimental
Period 1 - A single dose of 4 tablets(CKD-501 1T, D759 1T, H053 2T) under fed condition.
Period 2 - A single dose of 2 tablets(CKD-393 2T) under fed condition.
干预措施: CKD-393 (Drug)
1
Experimental
Period 1 - A single dose of 4 tablets(CKD-501 1T, D759 1T, H053 2T) under fed condition.
Period 2 - A single dose of 2 tablets(CKD-393 2T) under fed condition.
干预措施: CKD-501, D759, H053 (Drug)
2
Experimental
Period 1 - A single dose of 2 tablets(CKD-393 2T) under fed condition.
Period 2 - A single dose of 4 tablets(CKD-501 1T, D759 1T, H053 2T) under fed condition.
干预措施: CKD-393 (Drug)
2
Experimental
Period 1 - A single dose of 2 tablets(CKD-393 2T) under fed condition.
Period 2 - A single dose of 4 tablets(CKD-501 1T, D759 1T, H053 2T) under fed condition.
干预措施: CKD-501, D759, H053 (Drug)
结局指标
主要结局
AUCt of CKD-501, D759, H053
时间窗: Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hour
AUCt: Area under the concentration-time curve from time zero to time
Cmax of CKD-501, D759, H053
时间窗: Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hour
Cmax: Maximum plasma concentration of the drug
次要结局
未报告次要终点
研究者
研究点 (1)
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