NCT01423526已完成1 期
A Dose Block-randomized, Double-blind, Placebo Controlled, Single-dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of DWP10292 After Oral Administration in Healthy Male Subjects
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Composite of Pharmacokinetics
研究概览
简要总结
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of orally administrated DWP10292 in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
- •Healthy adult male subjects aged 20 to 45 years
- •The subject has a Body weight ≥ 60 kg and < 90 kg and Body Mass Index (BMI) ≥ 18.5 kg/m2 and < 27.0 kg/m2
- •A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)
排除标准
- •A subject with sign or symptoms or previously diagnosed disease of liver (viral hepatitis), digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse
- •A subject who shows vital signs with the number of systolic blood pressure of ≥140 mmHg or ≤100 mmHg, and the number of diastolic blood pressure of ≥90mmHg or ≤60mmHg
- •A subject who shows the following result in clinical laboratory test:
- •AST,ALT>1.25 times of the upper limit of normal range
- •QTc>430msec
- •T.bil>1.25 times of the upper limit of normal range
- •A subject from whom over 400mL of blood was sampled(whole blood or plasma donation, etc.) within last 8 weeks
- •Subject who has taken other clinical or licensed medication from another clinical trial within an 8-week period prior to the first administration of the study medication (The last administration of the medication is considered as an end point of the previous clinical trial).
- •Subject who smokes an average of 10 cigarettes/day and is unable to quit smoking during the clinical trial.
研究组 & 干预措施
Placebo
Placebo Comparator
Drug: Placebo tablets, oral administration, single administrations
Arms: Placebo
干预措施: Placebo (Drug)
DWP10292
Experimental
Drug: DWP10292 tablets, oral administration, single administrations
Arms: DWP10292
干预措施: DWP10292 (Drug)
结局指标
主要结局
Composite of Pharmacokinetics
时间窗: 0 (predose), 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 24 (2d 0h), 36, 48 (3d 0h), 60, 72 (4d 0h), 96 h(5d 0h) and Post study visit 216h (10d 0h)
Cmax, AUClast, AUCinf, Tmax, t1/2, CL/F
次要结局
- Safety&tolerability(0 (predose), 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 24 (2d 0h), 36, 48 (3d 0h), 60, 72 (4d 0h), 96 h(5d 0h) Post study visit 216h (10d 0h))
研究者
研究点 (1)
Loading locations...
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