CTRI

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CTRI Number

CTRI/2024/02/062402 [Registered on: 07/02/2024] Trial Registered Prospectively

Last Modified On:

23/02/2024

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Nutraceutical

Study Design

Single Arm Study

Public Title of Study

Research on Palmitoylethanolamide (PEA) Extract in Healthy People

Scientific Title of Study

Pharmacokinetic Study of Palmitoylethanolamide (PEA) Extract in Healthy Human Volunteers.

Trial Acronym

Nil

Secondary IDs if Any
Modification(s)

Secondary ID	Identifier
MHC/CT/23-24/026 Version: 2.00; Dated, 06 February 2024	Protocol Number
MHC/CT/23-24/026, Version: 1.00; Dated 27 November 2023	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr V G Vaidya
Designation	Principal Investigator
Affiliation	Lokmanya Medical Research Centre
Address	Fourth-floor OPD 401 314 B Telco Road Chinchwad Pune Pune MAHARASHTRA 411057 India
Phone	9822057766
Fax	-
Email	vgvclinical@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Gayatri Ganu
Designation	Managing Director
Affiliation	Mprex Healthcare Pvt. Ltd.
Address	501-514, Crossroads, Wakad, Pune Pune MAHARASHTRA 411057 India Pune MAHARASHTRA 411057 India
Phone	8554912644
Fax	-
Email	drgayatri@mprex.in

Details of Contact Person
Public Query

Name	Dr Gayatri Ganu
Designation	Managing Director
Affiliation	Mprex Healthcare Pvt. Ltd.
Address	501-514, Crossroads, Wakad, Pune Pune MAHARASHTRA 411057 India Pune MAHARASHTRA 411057 India
Phone	8554912644
Fax	-
Email	drgayatri@mprex.in

Source of Monetary or Material Support

Tilman SA, Zoning industriel Sud 15 BE-5377 Baillonville, Belgium

Primary Sponsor

Name	Tilman SA
Address	Zoning industriel 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

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr V G Vaidya	Lokmanya Medical Research Centre and Hospital	4th-floor OPD 401 314 B Telco Road Chinchwad Pune Pune MAHARASHTRA	9822057766 - vgvclinical@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 of Lokmanya Medical Research Centre	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Healthy Human Volunteers

Intervention / Comparator Agent
Modification(s)

Type	Name	Details
Intervention	Formulation A: Palmitoylethanolamide	Dose: 500 mg (2 capsules containing 500 mg of pure palmitoylethanolamide), Frequency: Single dose - once only, Route of Administration: Oral, Duration- Single dose.
Intervention	Formulation B: Palmitoylethanolamide (water dispersed)	Dose: 500 mg (2 capsules containing 500 mg of pure palmitoylethanolamide), Frequency- Single dose - once only, Route of Administration: Oral, Duration: Single dose.
Intervention	Formulation C: Micronized Palmitoylethanolamide	Dose: 500 mg (4 capsules containing 500 mg of micronized palmitoylethanolamide), Frequency- Single dose - once only, Route of Administration: Oral, Duration: Single dose.
Intervention	Formulation D: Liposomal palmitoylethanolamide	Dose: 30 ml (containing 300 mg liposomal palmitoylethanolamide), Frequency: Single dose - once only, Route of Administration: Oral, Duration- Single dose.
Intervention	Formulation E:Liposomal palmitoylethanolamide	Dose: 20 ml (containing 300 mg liposomal palmitoylethanolamide), Frequency: Single dose - once only, Route of Administration: Oral, Duration- Single dose.
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 kg per m2 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 per day or inability to abstain during the study;
14. Trial participant consumed tobacco or 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. Males 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	Pharmacokinetic blood samples will be collected at pre-dose [within 45 min before IP administration] and post-dose at 30 min; 45 min; 70 min; 90 min; 120 min; 180 min; 240 min. (Total 8 Time points).

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 study

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60"

Phase of Trial

Phase 2

Date of First Enrollment (India)

16/02/2024

Date of Study Completion (India)

21/04/2024

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="2"
Days="0"