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临床试验/NCT03616392
NCT03616392已完成1 期

A Randomized, Open-label, Multiple Dose, 2-way Crossover Study to Evaluate the Drug Drug Interaction of CKD-501 and D308 in Healthy Volunteers

Chong Kun Dang Pharmaceutical1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2018年7月25日最近更新:
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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
41
试验地点
1
主要终点
(Part 1) AUCss,tau of D308
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Phase 1 trial to evaluate the drug drug interaction of CKD-501 and D308

详细描述

A randomized, open-label, multiple dose, 2-way crossover study to evaluate the drug drug interaction of CKD-501 and D308 in healthy volunteers

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 —（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Healthy adult older than 19 years at the time of screening
  • •BMI 17.5~30.5kg/m2 and body weight more than 55kg
  • •Subject who has no chronic disease within last 3 years and no symptoms or pathological findings
  • •Suitable subject who is determined to be suitable at the time of screening such as laboratory tests(hematology, blood chemistry, urinalysis, virus/bacteriological test, etc.), sign of vitality, electrocardiogram
  • •Subject who signed the written consent of the Chonbuk National University Hospital IRB to participate in this study with full understanding of the purpose and contents of the examination prior to the clinical trial
  • •Subject who has will and ability to participate in clinical trials

排除标准

  • •Subject who has a history of clinical significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, psychiatric, neurological or allergic diseases(except for asymptomatic seasonal allergies not treated at the time of administration) or evidence(except for simple dental history such as dental calculus, impacted tooth, wisdom tooth, etc.)
  • •Subject with a history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption
  • •Clinical laboratory test results showing the following values
  • •* ALT or AST > 2 times upper limit of normal range
  • •Subject who has a history of regular alcohol consumption exceeding 210g/week within 6months of screening (1 glass of beer(5%)=10g, 1 glass of soju(20%)=8g, 1 glass of wine(12%)=12g)
  • •Those taking other clinical trial drugs or bioequivalence test drugs within 3months before the first administration of clinical trial drug
  • •Subject who has a systolic blood pressure of less than 100mmHg or more than 140mmHg or diastolic blood pressure of less than 60mmHg or more than 90mmHg of screening
  • •Subject who has significant alcohol abuse or drug abuse within a year of screening
  • •Those taking medication known to significantly induce or inhibit drug metabolizing enzymes within 30days prior to the first administration of clinical trial medication
  • •More than 20 smokers per day within six months of screening
  • •Those taking prescription or non-prescription drugs within 10days before the first administration of clinical trial medication
  • •Those who donated whole blood within 2 months or those who donated the components within 1 month before the first administration of the clinical trial drug
  • •Subject who has risk of serious or chronic medical, mental, or laboratory examinations that may increase the risk due to the administration of medicines for clinical trials and may interfere with the interpretation of test results
  • •Patients who are known to be hypersensitive to the drug or its components
  • •Patients with severe heart failure or heart failure(New York Heart Association(NYHA) Class 3, 4 heart patients)
  • •Patients with hepatic impairment
  • •Patients with a glomerular filtration rate(eGFR) less than 60ml/min/1.73m2, patients with end stage renal disease or dialysis
  • •Patients with diabetic ketoacidosis, diabetic coma and total coma, patients with type 1 diabetes
  • •Before and after surgery, severe infectious patients, severe trauma patients
  • •Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • •Pregnant and lactating women
  • •Subject who is judged by the investigator to be ineligible to participate in the clinical trial

研究组 & 干预措施

Part 1: Group 1(Treatment A/Treatment B)

Experimental

Period 1: Treatment A (D308 1T)/day for 5days, QD, PO Period 2: Treatment B (D308 1T + CKD-501 1T)/day for 5days, QD, PO

干预措施: D308, CKD-501 (Drug)

Part 1: Group 2(Treatment B/Treatment A)

Experimental

Period 1: Treatment B (D308 1T + CKD-501 1T)/day for 5days, QD, PO Period 2: Treatment A (D308 1T)/day for 5days, QD, PO

干预措施: D308, CKD-501 (Drug)

Part 2: Group 1(Treatment C/Treatment B)

Experimental

Period 1: Treatment C (CKD-501 1T)/day for 5days, QD, PO Period 2: Treatment B (D308 1T + CKD-501 1T)/day for 5days, QD, PO

干预措施: D308, CKD-501 (Drug)

Part 2: Group 2(Treatment B/Treatment C)

Experimental

Period 1: Treatment B (D308 1T + CKD-501 1T)/day for 5days, QD, PO Period 2: Treatment C (CKD-501 1T)/day for 5days, QD, PO

干预措施: D308, CKD-501 (Drug)

结局指标

主要结局

(Part 1) AUCss,tau of D308

时间窗: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

Area under the curve of D308 at steady state

(Part 1) Css,max of D308

时间窗: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

Max Concentration of D308 at steady state

(Part 2) AUCss,tau of CKD-501

时间窗: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

Area under the curve of CKD-501 at steady state

(Part 2) Css,max of CKD-501

时间窗: Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

Max Concentration of CKD-501 at steady state

次要结局

  • (Part 1) Tss,max of D308(Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours)
  • (Part 1) Css,min of D308(Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours)
  • (Part 1) Css,av of D308(Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours)
  • (Part 1) t1/2 of D308(Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours)
  • (Part 1) CLss/F of D308(Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours)
  • (Part 1) Vdss/F of D308(Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours)
  • (Part 1) Fluctuation[(Css,max-Css,min)/Css,av] of D308(Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours)
  • (Part 1) Swing[(Css,max-Css,min)/Css,min] of D308(Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours)
  • (Part 2) Css,min of CKD-501(Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours)
  • (Part 2) Css,av of CKD-501(Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours)
  • (Part 2) Tss,max of CKD-501(Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours)
  • (Part 2) t1/2 of CKD-501(Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours)
  • (Part 2) CLss/F of CKD-501(Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours)
  • (Part 2) Vdss/F of CKD-501(Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours)
  • (Part 2) Fluctuation[(Css,max-Css,min)/Css,av] of CKD-501(Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours)
  • (Part 2) Swing[(Css,max-Css,min)/Css,min] of CKD-501(Day 1, 3, 4 predose(0 hour) and Day 5 predose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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