Clinical Research Directory

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

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.

Beneficial Effects of Supplementation With CRONILIEF™ (Palmitoylethanolamide Phospholipids) in Diabetic Subjects With Neuropathic Pain.

This study aims to evaluate the potential benefit of an oral nutritional supplement based on CRONILIEF™ (Palmitoylethanolamide Phospholipids) in diabetic subjects with neuropathic pain, compared to a placebo.

Palmitoylethanolamide vs Ibuprofen for Pain After ESWL

Pain after extracorporeal shock wave lithotripsy (ESWL), a non-surgical procedure used to treat kidney stones, is common and is usually treated with non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen. However, NSAIDs may cause side effects in some patients, including stomach irritation and kidney problems. Palmitoylethanolamide (PEA) is a naturally occurring substance in the body with anti-inflammatory and pain-relieving properties and has been shown to be safe in previous studies. This study aims to compare the effectiveness of PEA with ibuprofen for controlling acute postoperative pain after ESWL. Participants undergoing ESWL will be randomly assigned to receive either oral PEA or oral ibuprofen. Pain intensity will be measured using a visual analogue scale during the first 24 hours after the procedure. The use of rescue pain medication and any side effects will also be recorded. The results of this study may help determine whether PEA can be an effective alternative to ibuprofen for the management of acute pain after ESWL.