A randomized, single-dose, double-blind, 4-way, 4-sequence, crossover, study to assess the bioavailability of DF-22 in comparison with unformulated ingredient 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: 2023年1月9日

试验速览

暂无简介。

•1.Subjects with a normal Vitamin D status
•2.Subjects with 25-OH vitamin D3 status in between 20-30ng/mL at the baseline.
•3.BMI between 19-26 kg/m2 (inclusive)
•4.Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening
•5.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 D3 supplements within 3 weeks prior to the screening.
•2.Subjects having symptoms of viral infection, including COVID-19 infection
•3.Subjects with known hypersensitivity to the investigational products
•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 who have participated in any clinical trial in the past 1 month.
•7.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