CTRI/2023/09/057212尚未招募4 期
A randomized, single-dose, double-blind, active-controlled, two-way crossover study to assess the oral bioavailability of FIL-Vitamin C in healthy volunteers. - Nil
试验速览
- 阶段
- 4 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
- •1.Subjects with Body mass index (BMI) of 18-25 kg/m2.
- •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.
- •5. History of
- •Irritable bowel syndrome, malabsorption or gastrointestinal abnormalities which may affect drug absorption, duodenal ulcer or gastric ulcer, gastritis.
- •Kidney disease, kidney stones, cardiac conditions.
- •Recent blood donation (within 1 month).
- •Current smoker or has quit smoking within last 3 months.
- •Alcoholism and/or drug abuse, or heavy drinkers.
- •Immunodeficiency disease.
- •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.
研究者
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