A randomized, single-dose, double-blind, active-control comparative, 2-way crossover, 2 sequence study to assess the bioavailability of curcuminoids formulations, Vicumin in comparison with Acumin supplementation in healthy volunteers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Assess the bioavailability of curcuminoids formulation, Vicumin in comparison with Acumin
研究概览
简要总结
This is a randomized, single-dose, double-blind,active-control comparative, 2-way crossover, 2-sequence study to comparethe of curcuminoids formulations,Vicumin incomparison with Acumin supplementation in healthy volunteers. A group of 16 healthyvolunteers willing to give a written informed consent will be screened on Visit1 to confirm the eligibility. Subjects fulfilling the eligibility criteria willbe randomized into 1 of 2-treatment sequences on Visit 2. On the morning of Day1, in each period, subjects will receive a single oral dose of their assignedformulation as per randomization scheme. A total of 8 blood samples will becollected in each of the two study periods. 10 days ofwashout period will be maintained between the study periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects who are willing to give their written informed consent and comply with the protocol requirements.
- •2.Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 3.Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study.
排除标准
- •1.Subjects who have consumed curcumin (turmeric) containing food 2 days prior to screening 2.Subjects having symptoms of viral infection, including COVID-19 infection 3.Pregnant or lactating women.
- •4.Subjects with known hypersensitivity to the investigational products.
- •5.Subjects who have participated in any clinical trial in the past 1 month.
- •6.Any subjects found to have entered in to the study in violation of this protocol or if the subject is uncooperative during the study.
- •7.Any other condition that in the opinion of the investigator that does not justify the subject’s participation in the trial.
结局指标
主要结局
Assess the bioavailability of curcuminoids formulation, Vicumin in comparison with Acumin
时间窗: Day 1(Period 1), Day 11(Period 2)
次要结局
- Safety of Curcuminioids formulations Vicumin and Acumin(Day 1(Period 1), Day 11(Period 2))