None listed
Conditions
Interventions
Intervention1: Placebo of Ivy leaf 8 mg Orodispersible Film 2.5 cm2: one Placebo of Ivy
leaf 8 mg Orodispersible Film 2.5 cm2 at ambient temperature in an upright
sitting position
Total Duration- Sin
Sponsors
Wooshin LaPache d.o.o.
Raptim Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Willing to provide written informed consent by parents and assent form if possible by child for participation in the study, and an ability to comprehend the nature and purpose of the study; Willing to be available for the entire study period and to comply protocol requirements; Normal, healthy, children of 2 to 5 years (both inclusive) of age; Normal health status as determined by baseline medical and medication history, vital signs measurements and physical examination at the time of screening as well as check-in of study period; Normal Developmental milestones according to age
Exclusion criteria
Exclusion criteria: Consumption of anything which may alter taste sensation 2 hours prior to dosing; Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, dermatological, immunological or psychiatric diseases, or organ dysfunction; Any major illness or hospitalized within 90 days prior to check-in; Any illness observed by the parents within 30 days prior to check-in; Use of any prescribed medication (including herbal medicines and vitamin supplements) or OTC products within 30 days prior to check-in and requirement of the same throughout the study; History or presence of significant gastric and/or duodenal ulceration; History or presence of significant oral condition which might impact assessment of acceptability; Difficulty in swallowing or oral conditions affecting saliva production; Participated in any clinical investigation in past 30 days prior to check-in;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the Acceptability (Swallowability and Palatability) of Placebo of Ivy leaf 8 mg Orodispersible Film 2.5 cm2 in normal, healthy children of 2 to 5 years oldTimepoint: To assess the Acceptability (Swallowability and Palatability) of Placebo of Ivy leaf 8 mg Orodispersible Film 2.5 cm2 in normal, healthy children of 2 to 5 years old | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess safety and tolerability of Placebo of Ivy leaf 8 mg Orodispersible Film 2.5 cm2.Timepoint: Vital signs measurements (blood pressure, pulse/heart rate, body temperature and respiratory rate) and general well-being will be assessed within 0.50 hour prior to dosing and at 0.50 and 1.00 hour post-dose ( 30 minutes of scheduled time) during the in-house stay Post-study safety evaluations will be performed after 2.00 hours post-dose or after children withdrawal/termination. | — |
Countries
India
Contacts
Public ContactDr Yashvant Khaire
Raptim Research Pvt. Ltd.,
Outcome results
None listed