A comparative bioavailability study of Palmitoylethanolamide formulations in healthy volunteers.
- Registration Number
- CTRI/2023/05/052853
- Lead Sponsor
- Akay Natural Ingredients Pvt. Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of the study is to assess the bioavailability of formulated Palmitoylethanolamide (FPEA-1-23) in comparison with normal unformulated Palmitoylethanolamide (UFPEA-1-23) supplementation.Timepoint: 0h, 0.25h,0.5h,0.75h, 1.00h, 1.5h, 2.00h, 3.00h, 4.00h, 5.00h, 8.00h, 12.00h
- Secondary Outcome Measures
Name Time Method Safety and tolerability of FPEA-1-23 in comparison with UFPEA-1-23 supplementation.Timepoint: Day 0, Period 1, period 2