NCT00969787已完成1 期
DWP05195 in Healthy Adult Male Volunteers
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年4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
- 80
- 试验地点
- 1
- 主要终点
- Assessment of Safety & tolerability: Adverse events, vital signs, 12-Lead ECG, laboratory safety variables and physical examination
研究概览
简要总结
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of orally administrated DWP05195 in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Double (Participant, 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
- •Healthy adult male subjects aged 20 to 45 years
- •The subject has a Body weight ≥ 50 kg and < 90 kg and Body Mass Index (BMI) ≥ 19.0 kg/m2 and < 27.0 kg/m2
- •A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
- •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 respiratory, cardiovascular, endocrinology, liver, kidney, gastrointestinal, hematology, neurology and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse
- •A subject who had any allergic history to any drug (prescription drug or OTC medication etc.)
- •A subject who had received treatment with below listed drug within specified period prior to the first dose of study medication
- •Within last 1 month: drug or food known CYP1A2 inducer or inhibitor
- •Within 2 weeks: Prescribed or herbal or Non-prescribed medicine
- •Within 3 days: Consumption of grapefruit juice/grapefruit containing products or orange juice/orange containing products, garlic extracted functional foods
- •Within 3 days: Consumption of alcohol or caffeine
- •A subject who had participated in any other clinical study within the last 12 weeks
- •A subject from whom over 400mL of blood was sampled(whole blood or plasma donation, etc.) within last 12 weeks
- •A Subject with the known evidence of the following infections or drug abuse
- •HIV, HBs, HCV
- •cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine
- •Smoker or smoking cessation within 1 month or ex-smoker with positive results by cotinine test
- •AST or ALT greater than 1.5 times the upper limit of reference range or QTc > 430 msec base on screening results
- •Blood pressure: SBP ≥ 140 mmHg, DBP ≤ 85 mmHg
- •A subject judged ineligible by the investigator to participate in this study for other reason containing clinical laboratory tests
研究组 & 干预措施
DWP05195
Experimental
干预措施: DWP05195 (Drug)
结局指标
主要结局
Assessment of Safety & tolerability: Adverse events, vital signs, 12-Lead ECG, laboratory safety variables and physical examination
时间窗: 72hr after drug administration
次要结局
- Pharmacokinetics: Cmax, tmax, AUC, and t½ in plasma / amount of drug, fraction, and CLr in urine Pharmacodynamics: Thermal NeuroSensory Analyser(72 hr after drug administration)
研究者
研究点 (1)
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