A randomized, single-dose, double-blind, active-controlled, two-way crossover study to assess the oral bioavailability of FIL-Vitamin C in healthy volunteers.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To estimate the plasma concentrations of Vitamin C following supplementation of FIL-Vitamin C and/or unformulated Vitamin C, in healthy volunteers.
研究概览
简要总结
This is a randomized, single-dose, double-blind, active-control comparative, two-way crossover, 2-sequence study to assess the comparative oral bioavailability of FIL-Vitamin C and unformulated Vitamin C supplementation in healthy volunteers. A group of 12 healthy volunteers willing to give a written informed consent will be screened on Visit 1 to confirm the eligibility. Subjects fulfilling the eligibility criteria will be randomized into 1 of 2-treatment sequences on Visit 2. The 2-treatment sequences are: Sequence 1: Treatment A and B; Sequence 2: Treatment B and A. There will be a wash out period of 7 days between 2 dosing days,
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects with Body mass index (BMI) of 18-25 kg/m
- •2.Subjects who are willing to give their written informed consent to participate in the study and comply with the protocol requirements.
- •3.Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening.
排除标准
- •1.Subjects who have consumed Vitamin C containing food 2 days prior to screening.
- •2.History of consumption medications known to interact with Vitamin C.
- •3.Subjects having symptoms of viral infection.
- •4.Pregnant or lactating women.
- •History of •Irritable bowel syndrome, malabsorption or gastrointestinal abnormalities which may affect drug absorption, duodenal ulcer or gastric ulcer, gastritis.
- •â€¢Kidney disease, kidney stones, cardiac conditions.
- •â€¢Recent blood donation (within 1 month).
- •â€¢Current smoker or has quit smoking within last 3 months.
- •â€¢Alcoholism and/or drug abuse, or heavy drinkers.
- •â€¢Immunodeficiency disease.
- •â€¢Allergy, medication or supplement use that influences the immune system.
- •6.Subjects with known hypersensitivity to the investigational products.
- •7.Subjects who have participated in any clinical trial in the past 1 month.
- •8.Any subjects found to have entered the study in violation of this protocol or if the subject is uncooperative during the study.
- •9.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 plasma concentrations of Vitamin C following supplementation of FIL-Vitamin C and/or unformulated Vitamin C, in healthy volunteers.
时间窗: Pre-dose sample, Post-dose sample at 30 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8hours & 12 hours
次要结局
- The safety & tolerability of FIL-Vitamin C Formulations