Design Factors for Evaluating Child Resistant Packaging testing for children safety and senior friendly
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Child test
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 the study: The minimum duration of the study will be 1 month.
**Number of subjects:**100 subjects Children aged between 42 to 51 months, Senior subjects aged 50 -70 years will be recruited in the study in 2 groups (50 children in 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 51.00 Month(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.
- •Have IEC/IRB approved consent form signed by subject, parent or guardian.
- •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.
- •No known issues with plastic or allergy.
- •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
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 friendly test
时间窗: one day
1) Proportion of successful openings within a given treatment.
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
4) Number of failed attempts
时间窗: one day
5) Average time to open
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