NCT00487968已完成1 期
Eltrombopag Pediatric Formulation Taste Testing in Healthy Adult Volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To establish a taste preference of eltrombopag in a pediatric formulation taken at initial dosing, 3hours, and 6 hours on Day 1 & 2.
研究概览
简要总结
Based on a need for a pediatric formulation of eltrombopag for the treatment of pediatric thrombocytopenia, this study will help determine the best tasting pediatric formulation of eltrombopag. Healthy adult volunteers who are able to taste bitterness and who do not have a high sensitivity to bitterness will be enrolled. The subjects will evaluate different formulations and rate them based on the bitterness and effectiveness of sweetners. The outcome of this study will help support a decision for a new pediatric formulation of eltrombopag.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy adult based on a medical evaluation by a responsible physician
- •male or female adult between 18 and 55 years old
- •female subjects who are not pregnant or lactating
- •females who are unable to have children must have documented medical verification
- •females who are able to have children must have a negative pregnancy test
- •capable of giving written informed consent
排除标准
- •subjects who are unable to taste bitterness or are extrememly sensitive to bitterness
- •participated in a clinical trial within 30 days
- •exposure to more than four new medicines within 12 months prior to the first day of dosing
- •history of sensitivity to any of the study medications
结局指标
主要结局
To establish a taste preference of eltrombopag in a pediatric formulation taken at initial dosing, 3hours, and 6 hours on Day 1 & 2.
时间窗: at initial dosing, 3hours, and 6 hours on Day 1 & 2.
次要结局
- - physical exam and an echocardiogram (ECG) will be done at Day 1 & 2(done at Day 1 & 2)
- Saftey will be monitored by: - vital signs and clinical labs will be taken at all visits(all visits)
研究者
研究点 (1)
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