NCT01563432已完成1 期
Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Febuxostat Between TMX-67 40mg 2 Tablets and Feburic® 80mg 1 Tablet in 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
- 30
- 试验地点
- 1
- 主要终点
- Pharmacokinetic characteristics (AUClast and Cmax)
研究概览
简要总结
This study was designed to compare and evaluate the pharmacokinetic characteristics of febuxostat after single oral administration of TMX-67 (test drug) and Feburic® tablet in healthy adults; and to evaluate safety and tolerance following a single-dose administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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 males aged between 20 and 45 years
- •Subjects whose weight is 50 kg or more and BMI is between 18 and 29 kg/m2
- •Subjects who were voluntarily decided to participate in the study and provided written informed consent to observe the directions
排除标准
- •Medical history which may influence adsorption, distribution, metabolism, excretion of the drug
- •Clinically significant active chronic disease(s)
- •Persons who are deemed ineligible for the study by the investigator according to the clinical laboratory test results or for other reasons
研究组 & 干预措施
febuxostat (TR)
Experimental
干预措施: Feburic® (Drug)
febuxostat (TR)
Experimental
干预措施: TMX-67 (Drug)
febuxostat (RT)
Experimental
干预措施: Feburic® (Drug)
febuxostat (RT)
Experimental
干预措施: TMX-67 (Drug)
结局指标
主要结局
Pharmacokinetic characteristics (AUClast and Cmax)
时间窗: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 24 hours post-dose
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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