NCT03200496已完成1 期
Comparisons of Pharmacokinetics and Safety/Tolerability Profiles Between DA-5206 and Talion® Under Fasting and Fed States in Healthy Male Subjects
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
- Area under the plasma concentration versus time curve (AUC)
研究概览
简要总结
This is Open-label, Randomized, 3-sequence study to compare of pharmacokinetics and safety/tolerability profiles betweens DA-5206, a SR formulation of bepotastine besilate and Talion®, a IR formulation of bepotastine besilate under fasting and fed states in healthy male subjects
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
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteer 19 years to 45 years
- •Body mass index in the range of 18 to 29 kg/m2 and body weight greater than 50 kg
- •The subjects personally signed and dated informed consent document after informed of all pertinent aspects of the study, fully understanding and determided spontaneously to participate
排除标准
- •Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, endocrine, urologic, immunologic, dermal, neurologic, or psychological disease or history of such disease
- •Subject with acute disease within 28 days before the first dose of Investigational product
- •Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug
- •Subjects who are unwilling or unable to use highly effective methods of contraception as outlined in this protocol for the duration of the study
研究组 & 干预措施
TALION®
Experimental
干预措施: TALION® (Drug)
DA-5206(Fasting)
Experimental
干预措施: DA-5206(Fasting) (Drug)
DA-5206(Fed)
Experimental
干预措施: DA-5206(Fed) (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC)
时间窗: 0~24hr
PK Parameter
Peak Plasma Concentration (Cmax)
时间窗: 0~24hr
PK Parameter
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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