NCT02380976已完成1 期
Phase 1 Clinical Trial of DW340 and DW330SR + DW1030 Co-administration in Healthy Male Volunteers
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
- 24
- 主要终点
- Cmax of DW1030
研究概览
简要总结
A randomized, open-label, single-dose, crossover Phase I Study to investigate the relative bioavailability of DW340 and DW330SR + DW1030 co-administration in healthy male 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
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age at screening visit only 20 healthy men over the age of 40 years or less
- •Screening visit, BMI measurement is more than 19 kg/m2 who are below 27 kg/m2
- •Screening vist, 90 mmHg ≤ SBP ≤ 140 mmHg, 50 mmHg ≤ DBP ≤ 90 mmHg
- •Fully understand the purpose of trial, test drug and follow the instructions of the trial, Those who voluntarily written consent that ability and decision to participate during the entire period of the test
排除标准
- •Those with a clinically significant history or character; Liver, kidney, digestive, respiratory, musculoskeletal, endocrine, neuropsychiatric, blood • tumor type, cardiovascular disease
- •Those with Gastrointestinal diseases that may affect the absorption of the IND or history of surgery
- •Those who have a clinically significant history of hypersensitivity to drug and food
- •Those with genetic problems, such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption
- •Within 60 days those taking the other clinical trial drug
- •Within 30 days those who take the drug metabolizing enzyme induction and inhibition drugs or prescription drugs
- •Within 30 days those who take food abnormally, that may affect ADME of drug
- •Within 60 days those who donate whole blood, within 30 days those who donate blood partially, receive transfusion
- •Within 14 days those who take OTC drug
- •Those who showing positive for drug abuse concerns in urine drug testing
- •Those who drink excessive alcohol or have history of alcoholism
- •Heavy smoker
- •and so on
研究组 & 干预措施
Test 1
Experimental
First phase: DW330SR+DW1030 7 days after Second phase: DW340
干预措施: DW340 (Drug)
Test 2
Experimental
First phase: DW340 7 days after Second phase: DW330SR+DW1030
干预措施: DW340 (Drug)
结局指标
主要结局
Cmax of DW1030
时间窗: 9 days
AUClast of DW340
时间窗: 9 days
AUClast of DW1030
时间窗: 9 days
Cmax of DW330SR
时间窗: 9 days
Cmax of DW340
时间窗: 9 days
AUClast of DW330SR
时间窗: 9 days
次要结局
未报告次要终点
研究者
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