NCT00967772已完成1 期
A Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics of Naftopidil After Oral Administration in Korean 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
- 16
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of naftopidil
研究概览
简要总结
The safety/tolerability and pharmacokinetics (PK) of Naftopidil (commercial name: Flivas) after oral administration will be investigated in Korean healthy male volunteers. All volunteers will be assigned to 2 groups and administered a lower single dose tablet (Period 1). After one week's wash-over period, the volunteers take higher dosages (Period 2).
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
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 males subjects, 20-45 years inclusive
- •Weight over 55 kg inclusive and Ideal Body Weight (IBW) between -20% and +20% inclusive
- •Written informed consent given
排除标准
- •Hypersensitivity to drugs(aspirin, antibiotics and so on) including naftopidil
- •History or presence of any clinically significant liver or kidney disease, gastrointestinal, cardiovascular, respiratory, endocrinal, musculoskeletal, neurologic/psychiatric, urinary, hematological, oncological pathology
- •Have a history of drug abuse, or show positive for drug abuse at urine screening
- •Have participated in another clinical study within 2 months prior to entering inth the study
- •Are considered ineligible by the investigator due to clinical laboratory results or any other relevant reasons
研究组 & 干预措施
Naftopidil
Experimental
干预措施: Naftopidil (Drug)
结局指标
主要结局
Pharmacokinetics of naftopidil
时间窗: Dec. 2009 (anticipated)
次要结局
未报告次要终点
研究者
研究点 (1)
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