A Randomized, Comparative, Single-Dose, Crossover, 3 Sequence Study to Assess the Bioavailability of Formulated Vitamin C (DELT) in Comparison with Liposomal and Reference Vitamin C Supplementations in Healthy Volunteers.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To estimate the concentrations of vitamin C in DELT vitamin C in comparison with conventional vitamin C and plain vitamin C supplementation.
研究概览
简要总结
This is a comparative single-dose, crossover, 3-sequence study to compare the bioavailability of DELT vitamin C in comparison with conventional vitamin C and plain vitamin C. A group of 12 Healthy volunteers willing to give a written informed consent will be screened on Visit 1 to confirm eligibility. Subjects fulfilling the eligibility criteria will be assigned into 1 of 3-treatment sequence on Visit 2 followed by cross-over to the other treatment sequences on subsequent visits. There will be washout period between each dosing day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Subject who agree not to consume any vitamin C based foods throughout the study.
- •Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening.
- •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 either Vitamin C containing food/supplement 7 days prior to screening.
- •2.Pregnant or lactating women.
- •3.Subjects with known hypersensitivity to the investigational products.
- •4.Subjects who have participated in any clinical trial in the past 1 month.
- •5.Any subjects found to have entered in to the study in violation of this protocol or if the subject is uncooperative during the study.
- •6.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
To estimate the concentrations of vitamin C in DELT vitamin C in comparison with conventional vitamin C and plain vitamin C supplementation.
时间窗: Period 1, Period 2, Period 3
次要结局
- Pharmacokinetics parameters of DELT vitamin C in comparison with conventional vitamin C and plain vitamin C.(Baseline, Day 9, Day 17)
- Safety and tolerability of DELT vitamin C in comparison with conventional vitamin C and plain vitamin C.(Baseline, Day 9, Day 17)
研究者
Dr Jayashree S Seeri
BGS Global Institute of Medical Sciences