NCT02332044已完成1 期
A Randomized, Open-label, Single Dose, Three-treatment, Three-period, Six-sequence Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Erdosteine and Bepotastine Besilate After Oral Administration in Healthy Volunteers
Daewoong Pharmaceutical Co. LTD.0 个研究点目标入组 36 人开始时间: 2014年4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
- 36
- 主要终点
- AUClast
研究概览
简要总结
The purpose of this study is to evaluate the drug-drug interaction between Erdosteine and Bepotastine besilate in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 male subjects aged 20 - 45 years
- •A body mass index in the range 18.5 - 25 kg/m2
- •Willingness to participate during the entire study period
- •Written informed consent after being fully informed about the study procedures
排除标准
- •Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease
- •History of clinically significant drug hypersensitivity
- •Use of medication within 7 days before the first dose
- •Heavy drinker/smoker
- •Whole blood donation during 60 days before the study
- •Judged not eligible for study participation by investigator
研究组 & 干预措施
Erdosteine 300mg
Experimental
干预措施: Erdos (Drug)
Bepotastine besilate 10mg
Experimental
干预措施: Talion (Drug)
Erdosteine 300mg + Bepotastine besilate 10mg
Experimental
干预措施: Erdos, Talion (Drug)
结局指标
主要结局
AUClast
时间窗: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment
Cmax
时间窗: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment
次要结局
未报告次要终点
研究者
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