Clinical Research Directory

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

Sponsor: S&R Farmaceutici S.p.A.

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.

Official title: A Comparative Crossover Pharmacokinetic Study of a Dietary Supplement: 600 mg of Ultra-micronized Palmitoylethanolamide (PEA) (Normast 600) Versus 600 mg of PEA in a Liposomal Formulation (AliaMed) in Healthy Subjects Following a Single Oral Dose.

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