NCT03628352已完成1 期
An Open-Label Taste Assessment of Tricaprilin Formulated as a Powder for Reconstitution in Healthy Panelists
Cerecin1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2018年9月10日最近更新:
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
- 9
- 试验地点
- 1
- 主要终点
- Taste as assessed by trained sensory panelists
研究概览
简要总结
This is an open-label multiple-dose study of the taste profile of tricaprilin formulated as a powder for reconstitution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The healthy male or female sensory panelist is between 25 and 80 years of age (inclusive) who volunteers for study participation and is able to read, understand, and sign and date a written informed consent form (ICF) before study participation.
- •The panelist is male, or is a non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol, or is a female of non-childbearing potential.
- •The sensory panelist is qualified based on training and experience.
- •The panelist is able to perform the required procedures according to the specified methodology
- •The panelist has provided full written consent to participate in the study.
排除标准
- •The sensory panelist has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the sensory panelist.
- •The sensory panelist has a known sensitivity to medium-chain triglycerides (MCTs) or any of the excipients used in study formulations.
- •The sensory panelist has a known history of kidney disease, inflammatory bowel disease, or Bradycardia. .
- •If female, the sensory panelist is pregnant, nursing, planning to become pregnant during the study.
- •Panelist must not have any planned hospitalizations or in-patient surgical procedures that are scheduled to take place during the study.
研究组 & 干预措施
Tricaprilin
Experimental
Approximately 5 mL liquid of tricaprilin using various flavoring agents (swish and expectorate) up to 20 times. Dose will not be ingested.
干预措施: Tricaprilin (Drug)
结局指标
主要结局
Taste as assessed by trained sensory panelists
时间窗: 1 day
single dose (swish and expectorate)
Texture as assessed by trained sensory panelists
时间窗: 1 day
single dose (swish and expectorate)
Smell as assessed by trained sensory panelists
时间窗: 1 day
Palatability as assessed by trained sensory panelists
时间窗: 1 day
single dose (swish and expectorate)
次要结局
未报告次要终点
研究者
研究点 (1)
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