A Single Center, Randomized, Double Blind, Placebo Controlled, Dose Escalation Clinical Trial to Evaluate Pharmacokinetic/Pharmacodynamic Characteristics and Safety of QDX After Single Oral Administration in Healthy Korean Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration (AUClast)
研究概览
简要总结
To evaluate pharmacokinetic/pharmacodynamic characteristics and safety of QDX after single oral administration in healthy Korean male subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Participants who have fully understood this clinical trial via detailed explanation, are willing to voluntarily participate in this study, and agree to give written informed consent which is confirmed from IRB.
- •Healthy male participants aged between 19 and 45 years at screening
- •Those whose body weight is over 50kg, and BMI is between 18.0 and 27.0
- •Participants who have demonstrated at least a 100 percent (%) increase in dermal blood flow in 30 minutes after capsaicin challenge as part of the screening procedures.
排除标准
- •Those who have a clinically significant disease of liver, kidney, digestive, respiratory, endocrine, neurologic, blood/tumor, cardiovascular system, or history of those diseases
- •Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to drugs (containing Topiramate etc.)
- •Those who have a hereditary galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption syndrome
- •Those who have irritating skin, wounds, eczema, and wounds on the area where capsaicin is applied
研究组 & 干预措施
Placebo
干预措施: Topiramate (Drug)
QDX 25
干预措施: Topiramate (Drug)
QDX 50
干预措施: Topiramate (Drug)
QDX 100
干预措施: Topiramate (Drug)
QDX 200
干预措施: Topiramate (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration (AUClast)
时间窗: Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
Time to Reach Maximum Plasma Concentration (Tmax)
时间窗: Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1
Tmax was defined as the time required to reach maximum observed plasma concentration.
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-T])
时间窗: Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.
Maximum Observed Plasma Concentration (Cmax)
时间窗: Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1
Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data.
The Capsaicin-Induced Dermal Blood Flow (DBF)
时间窗: Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 24 hour post-dosing on Day1
Change from Baseline in Dermal Blood Flow Induced by QDX Compared to Placebo
次要结局
未报告次要终点