None listed
Conditions
Interventions
Intervention1: IP A (FPEA-1-23): Single day administration of 200mg single oral dose
Control Intervention1: IP B (UFPEA-1-23): Single day administration of 200mg single oral dose
Sponsors
Akay Natural Ingredients Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Safety and tolerability of FPEA-1-23 in comparison with UFPEA-1-23 supplementation.Timepoint: Day 0, Period 1, period 2 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed