A randomized, single-dose, double-blind, 2-way crossover, 2 sequence study to assess the bioavailability of formulated Vitamin C (F-CAS-70) in comparison with normal unformulated Vitamin C (UF-CAS-70)supplementation in healthy volunteers.

Akay Natural Ingredients Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Subjects with a normal Vitamin C status
•2.BMI between 18-25 kg/m2 (inclusive)
•3.Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening
•4.Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study

•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, including COVID-19 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 3months, Alcoholism and/or drug abuse, or heavy drinkers, Immunodeficiency disease (e.g., human immunodeficiency virus infection,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 in to 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 subjectâ??s participation in the trial.

发起方

Akay Natural Ingredients Pvt Ltd