CTRI/2022/04/041683尚未招募1 期
Safety, Tolerability and Sensory Evaluation of Mentat Syrup in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Adult population:
- •1. Healthy adult subjects of either sex aged between >= 18 to <= 50 years.
- •2. Subjects willing to refrain taking any other similar medication during the study period
- •3. Adult subjects who have not participated in this kind of trial in the past 4 weeks
- •4. Adult subjects willing to sign informed consent and follow the study procedure.
- •Pediatric Population:
- •1. Healthy male and female pediatric subjects aged between >=2 years to <=12 years.
- •2. Parents/Guardians/Caregiver related to pediatric subjects < 7 years willing to give informed consent for his/her child to participate in the study.
- •3. Pediatric subjects aged > 7 years of age willing to provide oral consent for his/her participation in the study along with parents/guardians/caregiver consent (Refer protocol section 11.4, Informed Consent Process)
- •4. Pediatric Subjects willing to refrain taking any other similar medication during the study period
- •5. Pediatric subjects who have not participated in this kind of trial in the past 4 weeks.
- •6. Subjects willing to sign informed consent/assent (as applicable) and follow the study procedure.
排除标准
- •1. Subjects with clinically significant serious cardiovascular, respiratory,
- •cerebrovascular, hepatic, renal disease, endocrinal, congenital or any other disorder.
- •2. A known history or present condition of allergic response to the study products its components or ingredients in the investigational product.
- •3. Pre-existing systemic disease necessitating long-term medications.
- •4. Subjects who refused to sign informed consent.
- •5. Pregnant and lactating women.
研究者
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