NCT03601910Unknown1 期
An Open-label, Randomized, Fasted, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetic Characteristics and Safety Between CKD-380 10mg and D308 10mg in Healthy Male Adults
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- AUCt of CKD-380 and D308
研究概览
简要总结
This study is an open-label, randomized, fasted, single-dose, 2-way crossover study to compare the pharmacokinetic characteristics and safety between CKD-380 10mg and D308 10mg in healthy male adults.
详细描述
To healthy male subjects of thirty-four (34), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Reference drug: D308 10mg Tab. / Test drug: CKD-380 10mg Tab.
Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •19 to 45 years old healthy male subject at the screening
- •Subject with a body weight more than 50kg and less than ±20% of ideal body weight at the screening(* Ideal body weight = {Height(cm) - 100}x0.9)
- •Subject who is able to provide written informed consent and decided on his own participation after understanding fully to hear a detailed explanation in the clinical study
排除标准
- •Subject who has a disease or history of clinically significant cardiovascular system, respirator, kidney, endocrine system, blood system, digestive system, central nervous system(CNS), urinary system, musculoskeletal system, psychiatric system or malignant tumor etc.
- •Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect investigational product absorption
- •Subject who has hypersensitivity to Investigational product(or additives) or any other medicines or medical history of clinically significant hypersensitivity
- •Subject who is determined unsuitable for clinical studyl participation by Health Examination(Disease, past disease history Physical, vital sign, Electrocardiography, laboratory test etc.) at the screening
- •Subject who has laboratory test results at the screening as below 1) AST or AST > 1.25 times upper limit of normal range 2) Total bilirubin > 1.25 times upper limit of normal range 3) eGFR (estimated Glomerular Filtration Rate) < 60 mL/min/1.73 m2 4) Positive results of HBsAg, Anti-HCV Ab, HIV Ag/Ab and Syphilis reagin test 5) Glucose(under fasting condition) < 50mg/dL or >110mg/dL
- •Subject who has hypersensitivity to investigational product, peanut, or bean
- •Subject with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
- •Subject who shows Systolic Blood Pressure ≥140 or <90 mmHg or Diastolic Blood Pressure ≥90 or <60 mmHg at screening after rest longer than 5 minute at the screening
- •Subject who has history of drug abuse
- •Subject who has too much caffeine and alcohol(Caffeine: > 5 cup/day, Alcohol > 210 g/week) / Smoker(>10 cigarettes/day)
- •Subject who had the Investigational Product(IP) administration at other clinical studies or bioequivalence tests within 90 days prior to the first IP administration
- •Subject who has taken drug-metabolizing enzyme induction and/or inhibition drug(such as barbital, etc.) within 30days prior to the first Investigational Product administration
- •Subject who has donated whole blood within 60 days or component blood within 30days prior to the first Investigational Product administration
- •Subject who has foods containing grapefruit within 7days prior to the first Investigational Product administration
- •Subject who has taken ETC(Ethical The Counter) Drug or herb medicine within 14 days or OTC(Over The Counter) Drug or vitamin supplement within 7 days prior to the first Investigational Product administration
- •Subject who is nat able to have foods containing caffeine, drinking alcohol or Smoking during from 24hours before admission to discharge hospitalization
- •Subject who is not eligible for participation in clinical study by investigator's decision including another reason
研究组 & 干预措施
A group
Experimental
- Period 1: D308 10mg Tab. 1T
- Period 2: CKD-380 10mg Tab. 1T
干预措施: D308 10mg Tab. (Drug)
A group
Experimental
- Period 1: D308 10mg Tab. 1T
- Period 2: CKD-380 10mg Tab. 1T
干预措施: CKD-380 10mg Tab. (Drug)
B group
Experimental
- Period 1: CKD-380 10mg Tab. 1T
- Period 2: D308 10mg Tab. 1T
干预措施: D308 10mg Tab. (Drug)
B group
Experimental
- Period 1: CKD-380 10mg Tab. 1T
- Period 2: D308 10mg Tab. 1T
干预措施: CKD-380 10mg Tab. (Drug)
结局指标
主要结局
AUCt of CKD-380 and D308
时间窗: Pre-dose(0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours
Area under the CKD-380/D308 concentration in blood-time curve from zero to the final
Cmax of CKD-380 and D308
时间窗: Pre-dose(0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours
The maximum CKD-380/D308 concentration in blood sampling time t
次要结局
未报告次要终点
研究者
研究点 (1)
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