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CTRI Number  CTRI/2025/03/082531 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 13/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Clinical Study Of Palmitoylethanolamide (PEA) Extract on healthy Volunteers 
Scientific Title of Study   Pharmacokinetic Study of Palmitoylethanolamide (PEA) Extract Formulations in Healthy Human Volunteers 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/24-25/061 Version: 1.00; Dated, 17 February 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramshyam Agarwal  
Designation  Principal Investigator 
Affiliation  Lokmanya Medical Research Centre and Hospital 
Address  4th floor OPD No 401 314 B Telco Road Chinchwad
-
Pune
MAHARASHTRA
411033
India 
Phone  8087282022  
Fax  -  
Email  ramshyam.research@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gayatri Ganu 
Designation  Managing Director 
Affiliation  Mprex Healthcare Pvt. Ltd. 
Address  office no 813 to 816 sai millenium punawale
-
Pune
MAHARASHTRA
411033
India 
Phone  8554912644  
Fax  -  
Email  clinical@mprex.in  
 
Details of Contact Person
Public Query  
Name  Dr Gayatri Ganu 
Designation  Managing Director 
Affiliation  Mprex Healthcare Pvt. Ltd. 
Address  office no 813 to 816 sai millenium punawale
-
Pune
MAHARASHTRA
411033
India 
Phone  8554912644  
Fax  -  
Email  clinical@mprex.in  
 
Source of Monetary or Material Support  
Tilman SA Zoning industrial Sud 15 BE-5377 Baillonville, Belgium. 
 
Primary Sponsor  
Name  Tilman SA 
Address  Zoning industrial Sud 15 BE-5377 Baillonville, Belgium 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ram Mundhe   Gunjkar Multispeciality Hospital  Spine Road Shivtej nagar chinchwad pune 411019
Pune
MAHARASHTRA 		 8454859082
-
drrammudhe.gunjkarresearch@gmail.com 
Dr Ramshyam Agarwal  Lokmanya Medical Research Centre and Hospital  4th floor OPD 401 314 B Telco Road Chinchwad
Pune
MAHARASHTRA 		 8087282022
-
ramshyam.research@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee Lokmanya Medical Research Centre  Approved 
Institutional Ethics Committee Sangvi Multispecialty Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Adults 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1.Formulation A   Group 1: Formulation A: 2 capsules containing 536 mg of Palmitoylethanolamide Levagen + equivalent to 500 mg of pure Palmitoylethanolamide.  
Intervention  2. Formulation B  Group 2: Formulation B: 4 capsules containing 523 mg of micronized Palmitoylethanolamide equivalent to 500 mg of pure Palmitoylethanolamide.  
Intervention  3. Formulations C  Group 3: Formulation C: 2 capsules containing 503 mg of ordinary Palmitoylethanolamide equivalent to 500 mg of pure Palmitoylethanolamide.  
Intervention  4. Formulation D   Group 4: Formulation D: 2 capsules containing 515 mg of ordinary Palmitoylethanolamide equivalent to 500 mg of pure Palmitoylethanolamide.  
Intervention  5. Formulations E   Group 5: Formulation E: 2 capsules containing 508 mg of Granulated Micronized Palmitoylethanolamide equivalent to 500 mg of pure Palmitoylethanolamide.  
Intervention  6. Formulations F  Group 6: Formulation F: 2 capsules containing 532 mg of Granulated Micronized Palmitoylethanolamide equivalent to 500mg of pure Palmitoylethanolamide.  
Intervention  7. Formulations G  Group 7: Formulation G: 2 capsules containing 596 mg of Granulated Micronized Palmitoylethanolamide equivalent to 500mg of pure Palmitoylethanolamide.  
Intervention  8. Formulation H  Group 8: Formulation H: 2 tablets containing 600 mg of Palmitoylethanolamide.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.Healthy male and female human trial participants aged between 18 and 55 years(both inclusive)
2.Female trial participants must have a negative urine pregnancy test prior to the housing
3.Male and females agreeing to use the contraceptive pill or abstinence as a method of
contraception during and 07 days after completion of the study
4.Trial participants with a BMI between 18.50-28.00 kgperm2 and body mass not less
than 50.00 kg
5.Trial participants in normal health as determined by personal medical history, clinical
examination including vital signs, and clinically acceptable results of laboratory examinations (including serological tests);
6.Trial participants having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording
7.Trial participants having a normal or clinically not significant chest X-ray (PA view);
8.A negative alcohol breath test result before housing
9.Trial participant able to communicate effectively and provide written informed consent
10.Trial participants willing to adhere to the protocol requirements as evidenced by
written informed consent approved by the ethics committee;
11.Trial participants that can provide adequate evidence of their identity
12.Availability of volunteers for the entire study duration
13.Ability to fast for at least 14.00 hours and consume standard meals 
 
ExclusionCriteria 
Details  1.Known hypersensitivity to PEA or related product or any component of any interventions;
2.Incapable of understanding the informed consent information;
3.Clinically significant medical condition, such as, but not limited to, cardiovascular neurological, psychiatric, pulmonary, renal, immunological, endocrine (including
uncontrolled diabetes or thyroid disease), or uncontrolled haematological abnormalities;
4.Any treatment which could bring about induction or inhibition of the hepatic microsomal enzyme system within one month of starting the study;
5.History or presence of alcoholism or drug abuse;
6.History or presence of asthma, urticaria, or other allergic reactions;
7.History or presence of gastric and/or duodenal ulceration;
8.History or presence of thyroid disease, adrenal dysfunction, or organic intracranial lesion;
9.History or presence of cancer;
10.Difficulty with donating blood;
11.Use of any prescribed medication (including herbal remedies) during the two weeks before the start of the study or OTC medicinal products (including herbal remedies) during the week before study initiation and throughout the study;
12.Use of medications such as benzodiazepines, anticonvulsants, or barbiturates for one month before the start of the study and throughout the study;
13.Smokers who smoke 9 or more cigarettes/day or inability to abstain during the study;
14.Trial participant consumed tobacco/tobacco-containing products, pan or pan masala, gutkha, and masala (containing beetle nut and tobacco) for at least 48.00 hours before initiation of the study and throughout the study;
15.Trial participant consumed caffeine and/or xanthine-containing foods or beverages (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) and grapefruit juice and poppy-containing foods for at least 48.00 hours before initiation of the study and throughout the study;
16.Major illness during the 90 days before screening;
17.Participation in a drug research study within 90 days of screening;
18.Donation of blood within 90 days of screening;
19. Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C, and VDRL;
20.History or presence of easy bruising or bleeding;
21.Abnormal diet pattern for whatever reason (e.g., low sodium, fasting, and high protein diets) during the four weeks preceding the study;
22.Pregnant women and nursing mothers;
23.Male and females of childbearing potential unwilling to employ appropriate and reliable method of contraception during the study till 07 days after the completion of the study;
24.Male volunteers willing to donate sperm during the study till 07 days after the completion of the study.
25.Consumption of dietary supplements likely to provide constituents similar to the investigational product in last 3 days 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Plasma pharmacokinetic parameters   TimePoints:
Predose: 45 min Before IP administration
Postdose:
1)At 30 min After IP administration
2)At 45 min After IP administration
3)At 70 min After IP administration
4)At 90 min After IP administration
5)At 120 min After IP administration
6)At 180 min After IP administration
7)At 240 min After IP administration
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Screening, pre-dose, and post-dose vital signs.
2.Clinical examination, ECG, chest X-ray, clinical laboratory testing(hematology, blood chemistry, liver function test (LFT), kidney function test(KFT), and other enzyme tests and urinalysis).
3.Adverse events, serious adverse events throughout the study.
4.Tolerability of the investigational product from administration to end of the study 		 From Screening to end of the study 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/03/2025 
Date of Study Completion (India) 11/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   PEA is an endocannabinoid-like lipid mediator with well-documented anti-inflammatory, analgesic, antimicrobial, immunomodulatory and neuroprotective effects. It is safe and well tolerated in animals and humans, offering therapeutic benefits in various conditions, including chronic pain, psychopathologies, and neurodegeneration. However, the endogenous levels of PEA may be insufficient in chronic inflammatory disorders, necessitating exogenous administration for therapeutic purposes PEA is a compound with poor solubility and poor bioavailability. Different formulations have been developed to increase the dispersion of PEA in water solution with the goal to increase the bioavailability while maintaining essential technical parameters such as bulk density and flowability. The goal of this study is to compare the bioavailability of different formulations containing PEA.
Conducting a pharmacokinetic study on PEA is crucial for optimizing its therapeutic use by understanding its absorption, distribution, metabolism, and excretion. This study provides essential information on bioavailability, dosage determination, administration frequency, duration of action, tissue distribution, metabolism, and safety. Knowledge of metabolic pathways and elimination routes helps identify potential drug interactions, ensuring safe elimination without toxicity or accumulation. 
Establishing a correlation between pharmacokinetic parameters and pharmacodynamic effects is also vital for optimizing therapeutic outcomes. Additionally, pharmacokinetic data informs the development of formulations, to maintain consistent plasma concentrations over time. Investigation of PEA’s pharmacokinetic profile will also contribute to understanding its safety and tolerability, including potential drug interactions and adverse effects. In pharmacokinetic studies, healthy human trial participants are preferred to assess the active ingredient’s behavior accurately. Including both males and females is crucial to identify potential gender-based differences in absorption, distribution, metabolism, and excretion. This research aims to explore the pharmacokinetic profile of PEA extract in healthy human volunteers following acute oral administration under fasting conditions.
 
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