Design Factors for Evaluating Child Resistant Packaging (Dropper) testing for children safety and senior friendly
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 4)Number of failed attempts
研究概览
简要总结
Protocol Title: Design factors for evaluating child resistant packaging testing for children safety and senior friendly.
Study Design: A single center observational study.
Duration of study: The minimum duration for the study will be one month.
Number of subjects : 100 subjects children aged between 42 to 51 months, senior subjects aged 50 to 70 years will be recruited in the study in 2 groups (50 children i n child test group ( Group-A), 50 senior subjects in senior test Group (Group-B)).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 42.00 Month(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged between 42 to 51 months, Senior subjects aged 50 -70 years at the time of testing 2) Have IEC/IRB approved consent form signed by subject, parent or guardi3) 3) Haver permission to be videotaped Provide verbal assent (or assent through body language- head nod, etc).
排除标准
- •No history of food allergies of any kind 2) No known issues with plastic or allergy 3) Have no physical or mental impairments that impact their ability to open packages.
- •Subjects with overt or obvious disabilities.
- •Adult subjects with a permanent or temporary illness, injury, or disability that would interfere with his/her effective participation.
结局指标
主要结局
4)Number of failed attempts
时间窗: One day
5)Average time to open
时间窗: One day
Child Test:
时间窗: One day
1) Proportion of successful openings within a given time (First five minutes OR Second five
时间窗: One day
minutes).
时间窗: One day
2) Time to successful opening (First five minutes OR Second five minutes) (Openings will be
时间窗: One day
recorded as child was successful yes/no).
时间窗: One day
Senior Test:
时间窗: One day
1)Proportion of successful openings within a given time.
时间窗: One day
2)Time to successful opening.
时间窗: One day
3)Number of successful attempts
时间窗: One day
次要结局
未报告次要终点
研究者
Dr Swati
Resyte Pharma Research Private Limited