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Ultra-Micronized vs Liposomal PEA 600 mg: A Crossover PK Study in Healthy Subjects

NCT07804758 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-09-04

No results posted yet for this study

Summary

This is a crossover pharmacokinetic study comparing two oral formulations of palmitoylethanolamide (PEA) as a dietary supplement: ultra-micronized PEA 600 mg (Normast 600) and liposomal PEA 600 mg (AliaMed), in 6 healthy subjects following a single oral dose.

Eligible subjects presenting at the Crabion S.r.l. research center for routine screening, who meet the inclusion criteria and provide informed consent, will be enrolled and allocated to one of two groups using non-random, systematic alternate allocation.

On Day 1, after a fasting baseline blood draw (T0), Group 1 subjects will receive a single 600 mg dose of ultra-micronized PEA (Normast 600), while Group 2 subjects will receive a single 600 mg dose of liposomal PEA (AliaMed). Subjects may eat breakfast immediately after dosing. Blood samples (\~3 mL each) will be collected at 0.5, 1, 2, 4, and 24 hours post-dose. Subjects will remain at the center for approximately 4 hours (through the penultimate draw) and will return the following morning for the final 24-hour sample. Subjects will be monitored throughout their stay and asked to report any adverse effects.

A 7-day washout period will follow. On Day 2 (post-washout), subjects will cross over to the alternate formulation: Group 1 will receive liposomal PEA and Group 2 will receive ultra-micronized PEA, each as a single 600 mg dose. Blood samples will be collected at the same time points as Day 1 (0.5, 1, 2, 4, and 24 hours) and analyzed per the same parameters.

Conditions

  • PK in Healthy Volunteers
  • Liposomal Encapsulation
  • Palmitoylethanolamide

Interventions

DIETARY_SUPPLEMENT

ultra-micronised PEA

Participants received ultra-micronised PEA followed by liposomal PEA after the washout period.

DIETARY_SUPPLEMENT

liposomal PEA

Participants received liposomal PEA followed by ultra-micronized PEA after the washout period.

Sponsors & Collaborators

  • S&R Farmaceutici S.p.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-13
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07804758 on ClinicalTrials.gov