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临床试验/NCT04651881
NCT04651881Unknown1 期

A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers Under Fed Conditions

Chong Kun Dang Pharmaceutical1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年10月27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
入组人数
24
试验地点
1
主要终点
Cmax of CKD-385
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

Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers under fed conditions

详细描述

A randomized, open-label, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fed conditions

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 aged more than 19 at the time of screening
  • •Those who had 18.0kg/m² ≤ Body Mass Index (BMI) < 30.0kg/m²
  • •# BMI=Weight(kg) / Height(m)²
  • •Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings on a medical examination.
  • •Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, urinalysis, serology), vital signs and ECG results at screening.
  • •Those who have voluntarily given written informed consents to participate in the study and to comply with all the instructions, based on full understanding of the nature of the study after listening to detailed explanations.
  • •Those who agree to double contraception method from the 1st dministration of the investigational product until 7 days after the last administration of investigational product.

排除标准

  • •Those who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases(except for simple dental history such as tartar, mpacted teeth, wisdom teeth).
  • •Those with a medical 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 of drug.
  • •Those who has a history of regular alcohol consumption in excess of 14 glasses/week for woman, 21 glasses/week for man within 1 months prior to screening.
  • •Those who received investigational products or bioequivalence test drugs within 6 months before the first administration of clinical trial drugs.
  • •Those who take drugs which may cause induction or inhibition of drug metabolism within 30 days before the first administration of investigational products.
  • •Those who have taken any drugs that may affect the clinical trial within 10 days.
  • •Those who donated whole blood within 2 months, or blood components within 2 week before first administration of investigational products.
  • •Those who is unable to consume a high-fat meal provided during the study.
  • •Those who are deemed insufficient to participate in this clinical study by investigators.

研究组 & 干预措施

Group 1

Experimental
  1. Period 1: Reference drug
  2. Period 2: Test drug 1
  3. Period 3: Test drug 2

干预措施: Reference drug (Drug)

Group 1

Experimental
  1. Period 1: Reference drug
  2. Period 2: Test drug 1
  3. Period 3: Test drug 2

干预措施: Test drug 1 (Drug)

Group 1

Experimental
  1. Period 1: Reference drug
  2. Period 2: Test drug 1
  3. Period 3: Test drug 2

干预措施: Test drug 2 (Drug)

Group 2

Experimental
  1. Period 1: Test drug 2
  2. Period 2: Reference drug
  3. Period 3: Test drug 1

干预措施: Reference drug (Drug)

Group 2

Experimental
  1. Period 1: Test drug 2
  2. Period 2: Reference drug
  3. Period 3: Test drug 1

干预措施: Test drug 1 (Drug)

Group 2

Experimental
  1. Period 1: Test drug 2
  2. Period 2: Reference drug
  3. Period 3: Test drug 1

干预措施: Test drug 2 (Drug)

Group 3

Experimental
  1. Period 1: Test drug 1
  2. Period 2: Test drug 2
  3. Period 3: Reference drug

干预措施: Reference drug (Drug)

Group 3

Experimental
  1. Period 1: Test drug 1
  2. Period 2: Test drug 2
  3. Period 3: Reference drug

干预措施: Test drug 1 (Drug)

Group 3

Experimental
  1. Period 1: Test drug 1
  2. Period 2: Test drug 2
  3. Period 3: Reference drug

干预措施: Test drug 2 (Drug)

Group 4

Experimental
  1. Period 1: Test drug 2
  2. Period 2: Test drug 1
  3. Period 3: Reference drug

干预措施: Reference drug (Drug)

Group 4

Experimental
  1. Period 1: Test drug 2
  2. Period 2: Test drug 1
  3. Period 3: Reference drug

干预措施: Test drug 1 (Drug)

Group 4

Experimental
  1. Period 1: Test drug 2
  2. Period 2: Test drug 1
  3. Period 3: Reference drug

干预措施: Test drug 2 (Drug)

Group 5

Experimental
  1. Period 1: Test drug 1
  2. Period 2: Reference drug
  3. Period 3: Test drug 2

干预措施: Reference drug (Drug)

Group 5

Experimental
  1. Period 1: Test drug 1
  2. Period 2: Reference drug
  3. Period 3: Test drug 2

干预措施: Test drug 1 (Drug)

Group 5

Experimental
  1. Period 1: Test drug 1
  2. Period 2: Reference drug
  3. Period 3: Test drug 2

干预措施: Test drug 2 (Drug)

Group 6

Experimental
  1. Period 1: Reference drug
  2. Period 2: Test drug 2
  3. Period 3: Test drug 1

干预措施: Reference drug (Drug)

Group 6

Experimental
  1. Period 1: Reference drug
  2. Period 2: Test drug 2
  3. Period 3: Test drug 1

干预措施: Test drug 1 (Drug)

Group 6

Experimental
  1. Period 1: Reference drug
  2. Period 2: Test drug 2
  3. Period 3: Test drug 1

干预措施: Test drug 2 (Drug)

结局指标

主要结局

Cmax of CKD-385

时间窗: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours

Maximum plasma concentration of CKD-385

AUCt of CKD-385

时间窗: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours

Area under the concentration-time curve from time zero to time of CKD-385

次要结局

  • AUCinf of CKD-385(Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours)
  • Tmax of CKD-385(Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours)
  • T1/2 of CKD-385(Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours)
  • CL/F of CKD-385(Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours)
  • Vd/F of CKD-385(Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 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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