A randomized, single-dose, double-blind, 2-way crossover, 2 sequence study to assess the bioavailability of formulated Palmitoylethanolamide (FPEA-1-23) in comparison with normal unformulated Palmitoylethanolamide (UFPEA-1-23) 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: 2023年5月29日

研究概览

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•1.Healthy volunteers who are not involved in any regular medication or supplementation.
•2.Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening
•3.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 Palmitoylethanolamide containing food 2 days prior to screening
•2.Subjects having symptoms of viral infection.
•3.Pregnant or lactating women.
•4.Subjects with known hypersensitivity to the investigational products.
•5.Subjects who have participated in any clinical trial in the past 1 month.
•6.Any subjects found to have entered in to the study in violation of this protocol or if the subject is uncooperative during the study.
•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