NCT01419470已完成1 期
Phase Ⅰ/Ⅱ Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044 After Oral Administration in Premature Ejaculation Patients
Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2011年2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
- 24
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
safety and tolerability, pharmacokinetics/efficacy of an escalating, repeat doses of YHD1044 in premature ejaculation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient is in a stable, monogamous sexual relationship with the same woman for at least 6 months and plans to maintain this relationship for the duration of the study
- •History of premature ejaculation in the 6 months before study initiation
- •History of intravaginal ejaculatory latency time (IELT) of < = 2 minutes in at least half of events
- •Premature Ejaculation Diagnostic Tool (PEDT) > =11
- •6 domains of International Index of Erectile Function(IIEF) >= 21
- •Patient and partner must agree to attempt sexual intercourse at minimum intervals specified in the protocol
- •Patient's partner must have a negative urine pregnancy test at time of screening
排除标准
- •Medical history which affects ADME in the past 3 years
- •Clinically significant and active disorder in ophthalmic system, gastro-intestine, cardiovascular, respiratory system, endocrine system, autoimmune system or malignant tumor,
- •Subjects with clinically significant observations considered as unsuitable based on medical judgment in the physical examination and clinical laboratory tests or a medical history
- •History of psychological disease
- •Clinically significant allergic disease
- •Hypersensitivity to TCA, SSRIs(Clomipramine, sertraline, fluoxetine, dapoxetine)
- •Taken dapoxetine within 3 months
- •Using other forms of therapy for treatment of PE (behavioral therapy or medications applied to the skin)
- •Taken another investigational drug within 1 month
- •History of drug abuse
研究组 & 干预措施
YHD1044 I
Experimental
干预措施: dapoxetine (Drug)
YHD1044 III
Experimental
干预措施: dapoxetine (Drug)
YHD1044 V
Experimental
干预措施: dapoxetine (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: throughout the study up to day 28
through physical examination, laboratory result, vital sign,ECG etc.
次要结局
- Cmax(Cmax,ss), Cmin,ss, AUCinf, AUCt, Tmax, CL/F(specified timepoints in the protocol)
- Efficacy(IELT)(13days, 28days)
研究者
研究点 (1)
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