Open label, Single-dose, Single Arm, Acceptability (Swallowability and Palatability) Study of Placebo of Ivy leaf 8 mg Orodispersible Film 2.5 cm2 of Wooshin LaPache d.o.o. in Normal, Healthy Children of 2 to 5 years old.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- To assess the Acceptability (Swallowability and
研究概览
简要总结
The purpose of the study is to acceptability (Swallowability and Palatability) Study of Placebo of Ivy leaf 8 mg Orodispersible Film 2.5 cm2 of Wooshin LaPache d.o.o. in Normal, Healthy Children of 2 to 5 years old. The primary objective of the study is 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 and the secondary objective is To assess safety and tolerability of Placebo of Ivy leaf 8 mg Orodispersible Film 2.5 cm2. The safety of childrens will be assessed by monitoring for occurrence of any AE as well as vital signs and general well-being during the in-house stay.No diet restrictions are required in the study. Childrens will be checked out after 2.00 hours post-dose. Post-study safety evaluations will be performed after 2.00 hours post-dose or after children withdrawal or termination
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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;.
结局指标
主要结局
To assess the Acceptability (Swallowability and
时间窗: 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
Palatability) of Placebo of Ivy leaf 8 mg Orodispersible Film 2.5 cm2 in
时间窗: 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
normal, healthy children of 2 to 5 years old
时间窗: 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
次要结局
- To assess safety and tolerability of Placebo of Ivy(leaf 8 mg Orodispersible Film 2.5 cm2.)
研究者
Dr Raviraj Jagdhani
Raptim Research Pvt. Ltd