Research on Palmitoylethanolamide (PEA) Extract in Healthy People
- Registration Number
- CTRI/2024/02/062402
- Lead Sponsor
- Tilman SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma pharmacokinetic parametersTimepoint: 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 Measures
Name Time Method 1.Screening, pre-dose, and post-dose vital signs. <br/ ><br>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). <br/ ><br>3.Adverse events, serious adverse events throughout the study. <br/ ><br>4.Tolerability of the investigational product from administration to end of the study. <br/ ><br>Timepoint: From screening to end of study