None listed
Conditions
Interventions
None listed
Sponsors
Sipra Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the child resistant effectiveness of the packaging 2. To assess the Ease of adult opening of the packaging 3. To assess the Adult â?? Resecuring Effectiveness of the packaging 4. To meet the Safety Closure Standards as per FDA, CFR Title 16, Part 1700 Timepoint: at the end of the 5 min. period. | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: None | — |
Countries
India
Contacts
Public ContactMs Nagalakshmi AnandaPadmanabhan
Sipra Labs Limited,
Outcome results
None listed