A Phase 1, Open-label, Randomized, 3-period Crossover Taste Assessment Study to Characterize the Palatability of SHP429 When the Contents Are Sprinkled Onto Soft Foods or Emptied Into a Cup and Administered With Water in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of Participants Willing to Take Mesalamine Via Treatment Method on a Regular Basis
研究概览
简要总结
The purpose of this study is to compare the palatability of SHP429 capsule contents delivered via 3 means of administration (sprinkled on yogurt, sprinkled on applesauce, and emptied into a cup and administered with water).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
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
- •normal, healthy, adult male and female volunteers, without evidence of active or chronic disease
排除标准
- 未提供
研究组 & 干预措施
Mesalamine (Vanilla Yogurt)
One 500mg capsule contents sprinkled onto 1 tablespoon of low-fat vanilla yogurt
干预措施: Mesalamine (Drug)
Mesalamine (Applesauce)
One 500mg capsule contents sprinkled onto 1 tablespoon of applesauce
干预措施: Mesalamine (Drug)
Mesalamine (Dosing Cup)
One 500mg capsule contents emptied into a dosing cup and taken with water
干预措施: Mesalamine (Drug)
结局指标
主要结局
Number of Participants Willing to Take Mesalamine Via Treatment Method on a Regular Basis
时间窗: Immediately post-dose
The participants were asked to answer "Yes" or "No" to the following question: "Would you be willing to take medicine this way on a regular basis if necessary?" The number of participants who answered "Yes" is reported.
Number of Participants With Positive Responses to Palatability Assessment of The Taste of Mesalamine
时间窗: Immediately post-dose
A taste assessment was completed immediately after investigational product was administered to assess the subject's taste/liking of the formulation. The assessment consisted of a 5-point rating scale. Participants were asked to choose one of the following responses to the statement "The taste was acceptable": strongly agree, agree, neutral, disagree, or strongly disagree. The number of participants who chose either of the top two responses (strongly agree, agree) is reported.
Number of Participants Who Detected an Aftertaste of Mesalamine
时间窗: 5 minutes post-dose
An aftertaste assessment was completed 5 minutes after administration of investigational product to assess whether the participants detected an aftertaste. The participants answered "Yes" or "No" to the following question: "Was there an aftertaste?" The number of participants who answered "Yes" is reported.
Number of Participants With Positive Responses to Palatability Assessment of The Aftertaste of Mesalamine
时间窗: 5 minutes post-dose
An aftertaste assessment was completed 5 minutes after administration of investigational product to assess the subject's rating of aftertaste and means of administration. The assessment consisted of a 5-point rating scale. The participants were asked to choose one of the following responses to the statement "The aftertaste (if present) was acceptable": strongly agree, agree, neutral, disagree, or strongly disagree. The number of participants who chose either of the top two responses (strongly agree, agree) is reported.
次要结局
- Number of Participants With Potentially Clinically Important Laboratory Results(1 day)
- Number of Participants Who Experienced an Adverse Event(4 days)
- Number of Participants With Potentially Clinically Important Vital Signs(1 day)
- Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Results(1 day)