Randomized, Open-label, Single Dose, Crossover Phase I Clinical Study to Evaluate the Pharmacokinetics of DW1029M 300 mg, 600 mg and 1200 mg After Oral Administration in Healthy Male Volunteer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Maximum Concentration of DW1029M in plasma
研究概览
简要总结
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Objective After single dose in healthy adults the capacity of the Group for DW1029M evaluate the pharmacokinetic characteristics.
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Indication Diabetic kidney disease
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Efficacy
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Primary
- AUClast, AUCinf, AUClast/D, AUCinf/D
- Cmax, Cmax/D
- Secondary
- Tmax, t1/2, CL/F, Vz/F
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Safety
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Adverse Event Monitoring
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V/S, EKG, Laboratory Test, P/E
详细描述
Healthy volunteers for clinical trials targeting drug administration date (1d) within 3 weeks from the (-21d ~-1d) in the interview, physical examination and laboratory tests , including through the screening is performed.
Through screening deems appropriate in this clinical trial is intended for the final subjects randomized to three groups to order .
The first phase one clinical trial subjects performed one day before (the -1 ) 18:00 Chonbuk National University Hospital, convened as a physical examination and perform hwalryeong signs .
One person to dinner , except for the drinking water should be fasting . One clinical trials (the first day) 20:00 subjects randomly assigned to groups according to the order in which the test is administered in a single oral medication .
The subjects for clinical trials with 240 mL water, medicines and swallow whole , chew before swallowing drugs should .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •More than 20 years of age at the time of screening and less than 55 years old healthy male
- •(17.5 ~ 30.5 kg/m2 body mass index (BMI) and weight 45 kg or more
- •☞ body mass index (BMI) = weight (kg) / height (m) 2
- •No congenital or chronic diseases, internal medicine examination results who does not have psychotic symptoms or findings
排除标准
- •Clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but, at the time of administration of seasonal allergic untreated asymptomatic except for sex), medical history or evidence
- •Drugs that may affect the absorption of all the states (eg, gastrectomy)
- •Investigational drugs within two months before the first dose participated in other clinical trials
研究组 & 干预措施
A Group
- 1st administration - DW1029M300mg PO Once
- 2nd administration - DW1029M600mg PO Once
- 3rd administration - DW1029M1200mg PO Once
干预措施: DW1029M300mg (Drug)
A Group
- 1st administration - DW1029M300mg PO Once
- 2nd administration - DW1029M600mg PO Once
- 3rd administration - DW1029M1200mg PO Once
干预措施: DW1029M600mg (Drug)
A Group
- 1st administration - DW1029M300mg PO Once
- 2nd administration - DW1029M600mg PO Once
- 3rd administration - DW1029M1200mg PO Once
干预措施: DW1029M1200mg (Drug)
B Group
- 1st administration - DW1029M600mg PO Once
- 2nd administration - DW1029M1200mg PO Once
- 3rd administration - DW1029M300mg PO Once
干预措施: DW1029M300mg (Drug)
B Group
- 1st administration - DW1029M600mg PO Once
- 2nd administration - DW1029M1200mg PO Once
- 3rd administration - DW1029M300mg PO Once
干预措施: DW1029M600mg (Drug)
B Group
- 1st administration - DW1029M600mg PO Once
- 2nd administration - DW1029M1200mg PO Once
- 3rd administration - DW1029M300mg PO Once
干预措施: DW1029M1200mg (Drug)
C Group
- 1st administration - DW1029M1200mg PO Once
- 2nd administration - DW1029M300mg PO Once
- 3rd administration - DW1029M600mg PO Once
干预措施: DW1029M300mg (Drug)
C Group
- 1st administration - DW1029M1200mg PO Once
- 2nd administration - DW1029M300mg PO Once
- 3rd administration - DW1029M600mg PO Once
干预措施: DW1029M600mg (Drug)
C Group
- 1st administration - DW1029M1200mg PO Once
- 2nd administration - DW1029M300mg PO Once
- 3rd administration - DW1029M600mg PO Once
干预措施: DW1029M1200mg (Drug)
结局指标
主要结局
Maximum Concentration of DW1029M in plasma
时间窗: 24 hours
次要结局
- Apparent clearance of DW1029M in Plasma(24hours)
- Apparent volume of distribution of DW1029M in Plasma(24hours)
- Time to maximal concentration of DW1029M in Plasma(24hours)
- Elimination half time of DW1029M in Plasma(24hours)
- Area under concentration-time curve of DW1029M in plasma(24hours)