Evaluation of the effectiveness of Caps on Round Bottles for their Safety Closure Standards as per the FDA Guidelines
- Registration Number
- CTRI/2011/12/002272
- Lead Sponsor
- Sipra Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 250
Inclusion Criteria for Children:
•Children aged between 42 â?? 51 months.
•Generally healthy (not having any serious diseases or indications or infections, which will be needing medical attention in a normal circumstance).
•Ability and willingness to give written informed consent by the Parent or guardian of each child.
Inclusion Criteria for Adults:
•Age 50 to 70 years (both inclusive).
•Generally healthy (not having any serious diseases or indications or infections, which will be needing medical attention in a normal circumstance).
•Ability and willingness to give written informed consent by the adults.
Exclusion Criteria for Children:
•No overt physical or mental handicaps.
•Subject has permanent or temporary illness, injury or disability that would interfere with his/her effective participation.
Exclusion Criteria for Adults:
•No overt physical or mental handicaps
•Subject has permanent or temporary illness, injury or disability that would interfere with his/her effective participation.
•Adult subject who is illiterate and not able to give consent for any other reason.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To assess the child resistant effectiveness of the packaging <br/ ><br>2.To assess the Ease of adult opening of the packaging <br/ ><br>3.To assess the Adult â?? Resecuring Effectiveness of the packaging <br/ ><br>4.To meet the Safety Closure Standards as per FDA, CFR Title 16, Part 1700 <br/ ><br>Timepoint: at the end of the 5 min. period.
- Secondary Outcome Measures
Name Time Method oneTimepoint: None