None listed
Conditions
Interventions
Intervention1: XanMax2002 capsule
: Dose : 364 mg of capsule
Frequency: single oral dose on day 0
Wash out period: 21 days
Control Intervention1: XanMax2002 + LuZeAbilityTM (self-emulsifier) capsul
Sponsors
Katra Phytochem (India) Private Limited
Daehan Chemtech CO LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male and female participants (non-pregnant) aged 18 45 years (both inclusive), with a body weight of at least 50 kg. 2. Participants willing to provide written informed consent and committed to adhering to study guidelines and procedures and availability throughout the study duration. 3. Participants with no evidence of underlying medical conditions as determined by medical history, physical examination, electrocardiogram (ECG), chest X-ray (posteroanterior view), and laboratory investigations performed within 7 days prior to study initiation. 4. Adherence to dietary restrictions, including limiting intake of lutein and zeaxanthin-rich foods (e.g., mangoes, tangerines, oranges, asparagus, broccoli, butternut squash, cilantro, collards, orange pepper, parsley, papaya, peas, pistachio, romaine lettuce, scallions, zucchini, kale, Brassica oleracea, spinach, carrots, corn, tomatoes, nectarines, and peaches etc.) to no more than 1 2 servings per day for at least one week prior to dosing and throughout the study. 5. Exclusion of eggs from the diet for at least two weeks prior to dosing and during the study period. 6. Non-smokers and non-alcohol users. 7. Negative screening results for HIV-1, HIV-2, and hepatitis B infections. 8. Participants with screening laboratory values within normal reference ranges or deemed clinically insignificant by the physician or Principal Investigator. 9. Female participants must meet one of the following criteria: a. Practicing a reliable method of contraception (e.g., condoms, diaphragm, IUD) throughout the study, or b. Postmenopausal for at least one year, or c. Surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, hysterectomy).
Exclusion criteria
Exclusion criteria: 1. Participants with a known allergy to XanMax 2002, lutein, zeaxanthin, or related compounds, food, or any medications. 2. Participants with resting blood pressure outside the range of 90/60 mmHg to 140/90 mmHg or a resting pulse rate below 50 beats per minute (bpm) or above 100 bpm. 3. Institutionalized individuals or those unable to provide informed consent. 4. History or presence of chronic illnesses, including diabetes, hypertension, liver or kidney disorders, cardiovascular or pulmonary diseases, gastrointestinal conditions, infections, dermatological disorders, or malignancies. 5. History or presence of thyroid dysfunction (hypo or hyperthyroidism). 6. Presence of alarm signs or symptoms, including fever, gastrointestinal bleeding, unintentional weight loss, unexplained anemia, dysphagia, or abdominal mass. 7. History of milk, gluten allergies or other known food intolerances and or any food allergies. 8. History of significant systemic diseases, seizures, psychiatric disorders, neurological disorders, depression, or mental illness and allergic rashes. 9. History of habitual intake of high caffeine (greterthan 5 cups of coffee or tea/day). 10. History of difficulty with blood donation or accessibility of veins. 11. History of drug or alcohol dependence. 12. Blood donation exceeding 350 mL within 90 days prior to the study. 13. Participation in another clinical study within the last 90 days. 14. Use of any prescription or over the counter medications (e.g., cold or antacid preparations), enzyme-modifying drugs, or vitamin or multivitamin supplements providing carotenoids (e.g multivitamins, lutein/zeaxanthin, beta carotene, lycopene, or beta cryptoxanthin or other carotenoids) within 30 days before screening. 15. Recent dehydration due to diarrhea, vomiting, or other causes within 24 hours prior to check-in. 16. Unusual dietary patterns (e.g., fasting for religious reasons) within 48 hours prior to check in. 17. Consumption of food and beverages containing xanthine (e.g., chocolates, tea, coffee or cola drinks) for at least two days prior to check in. 18. Consumption of grapefruit, sweet lime, or similar citrus fruits or juices within seven days prior to check in. 19. History of supplementation with macular carotenoids, omega 3 fatty acids, or alpha lipoic acid within 14 days before the study. 20. History of use of enzyme inducers (e.g., rifampicin, phenobarbitone, etc.) or enzyme inhibitors (e.g. erythromycin, fluconazole, etc.) within the last 14 days prior to check-in. 21. Positive results for drugs of abuse (e.g., benzodiazepines, barbiturates, opioids, cannabinoids, etc.) or alcohol breath tests at check-in. 22. Female participants with a positive pregnancy test, those who are breastfeeding, or those likely to become pregnant during the study. 23. Use of implanted or injected hormonal contraceptives within six months prior to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of XanMax 2002 (20 mg of lutein and trans-zeaxanthin in a 10:1 ratio) capsule compared to XanMax 2002 plus LuZeAbilityTM (self-emulsifier) capsuleTimepoint: Single venous blood sample will be withdrawn at 0.00 hours 0.5 hours, 1.00 hour 2.00 hours, 4.00 hours, 8.00 hours , 12.00 hours , 24.00 hours , 48.00 hours, and 72.00 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence, severity, and relationship of adverse events (AEs). Changes from baseline in clinical laboratory parameters (hematology, biochemistry, and urinalysis). Changes in vital signs (heart rate, blood pressure, respiratory rate, and body temperature). Findings from physical examinations (PEs). Timepoint: Screening to end of the study of study Period 2 including 21 days wash out period | — |
Countries
India
Contacts
Public ContactMs Priya M K
Katra Phytochem (India) Pvt Ltd
Outcome results
None listed