Bioavailability of Two Mitopure Formulations

Who cannot join

• 1. Known hypersensitivity to Urolithin A or related product or any component of intervention, presence or history of drug hypersensitivity, allergic disease or lactose intolerance; 2. Any history or presence of clinically significant medical condition, such as, but not limited to, cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease, thyroid disease, adrenal dysfunction, or organic intracranial lesion; 3. Any treatment which could bring about induction or inhibition of the hepatic microsomal enzyme system within one month of starting the study; 4. History or presence of alcoholism or drug abuse; 5. History or presence of gastric and/or duodenal ulceration; 6. History or presence of cancer; 7. Difficulty with donating blood; 8. 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; 9. Use of medications such as benzodiazepines, anticonvulsants, or barbiturates for one month before the start of the study and throughout the study; 10. 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; 11. Trial participant consumed caffeine and/or xanthine-containing foods or beverages (i.e., coffee, tea, chocolate, and caffeinecontaining sodas, colas, etc.) and grapefruit juice and poppycontaining foods for at least 48.00 hours before initiation of the study and throughout the study; 12. Major illness during the 90 days before screening; 13. Participation in a drug research study within 90 days of screening; 14. Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C, and VDRL; 15. History or presence of easy bruising or bleeding; 16. Abnormal diet pattern for whatever reason (e.g., low sodium, fasting, and high protein diets) during the four weeks preceding the study; 17. Females of childbearing potential with any one of the following reported and documented on the medical history: i. Postmenopausal with spontaneous amenorrhea for at least one year, or ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iii. Total hysterectomy and an absence of bleeding for at least 3 months; iv. Female volunteers who have used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 07 days before dosing; 18. Pregnant women and nursing mothers; 19. Male and females of childbearing potential unwilling to employ appropriate and reliable method of contraception like nonhormonal intrauterine devices, barrier methods, and spermicidal agents, Double Barrier method (Condom) during the study till 07 days after the completion of the study; 20. Male volunteers willing to donate sperm during the study till 07 days after the completion of the study. 21. Known allergy or hypersensitivity to any active ingredient or excipient in Formulation A or B, including urolithin A, zinc, lutein, astaxanthin, glucosylceramide, vitamin D3, quercetin, MCT oil, sunflower lecithin, or capsule excipients.