None listed
Conditions
Interventions
Intervention1: Lutein 18.18 mg / Zeaxanthin 1.82 mg / Astaxanthin
12 mg with LuZeAbility capsule
: administered orally single dose
Control Intervention1: Lutein 18.18 mg / Zeaxanthin 1.82 mg / Asta
Sponsors
DAEHAN CHEMTECH CO., LTD.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and non-pregnant female subjects, age in the range of 18 to 45 years (both inclusive). 2. Body weight of at least 50 kgs. 3. Subjects with normal findings as determined by baseline history, physical examination and vital sign examination (blood pressure, pulse rate, respiration rate and axillary temperature). 4. 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. 5. Participants with screening laboratory values within normal reference ranges or deemed clinically insignificant by the physician or Principal Investigator. 6. Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or grapefruit juice and tobacco products for 48 hours prior to dosing until after the last blood sample collection in the study. 7. Adherence to dietary restrictions, including limiting intake of lutein, zeaxanthin, and astaxanthin-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, peaches, salmon, shrimp, and lobster etc.) to no more than 1 2 servings per day for at least one week prior to dosing and throughout the study. 8. Exclusion of eggs from the diet for at least two weeks prior to dosing and during the study period. 9. Negative screening results for HIV-1, HIV-2, and hepatitis B infections. 10. Adherence to fluid and posture restrictions during the in-house. 11. No history of significant alcoholism. 12. Subjects who are able to communicate effectively. 13. No history of drug abuse for the last 6 months. 14. Non-alcoholics and non-smokers will be included. 15. 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) Post- menopausal for at least one year or c) Surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, hysterectomy).
Exclusion criteria
Exclusion criteria: 1. Known history of hypersensitivity to the study products (Lutein, Zeaxanthin, Astaxanthin or related compounds, food or any medication. 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 ( greater than5 cups of coffee or tea/day). 10. History of difficulty with blood donation or accessibility of veins. 11. Any contraindications to blood sampling 12. History of drug or alcohol dependence. 13. History of difficulty in swallowing oral solids such as Tablets, Capsules etc., 14. Blood donation exceeding 350 mL within 90 days prior to the study. 15. Participation in another clinical study within the last 90 days of the start of the study. 16. 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, astaxanthin, beta-carotene, lycopene, or beta-cryptoxanthin or other carotenoids) within 30 days before screening. 17. Recent dehydration due to diarrhea, vomiting, or other causes within 24 hours prior to check-in. 18. Unusual dietary patterns (e.g., fasting for religious reasons) within 48 hours prior to check-in. 19. Consumption of food and beverages containing xanthine (e.g., chocolates, tea, coffee or cola drinks) for at least two days prior to check-in. 20. Consumption of grapefruit, sweet lime, or similar citrus fruits or juices within seven days prior to check-in. 21. History of supplementation with macular carotenoids, omega-3 fatty acids, or alpha-lipoic acid within 14 days before the study. 22. 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. 23. Positive results for drugs of abuse (e.g., benzodiazepines, barbiturates, opioids, cannabinoids, etc.) or alcohol breath tests at check-in. 24. Female participants with a positive pregnancy test, those who are breastfeeding, or those likely to become pregnant during the study. 25. Use of implanted or injected hormonal contraceptives within six months prior to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of Lutein 18.18 mg / Zeaxanthin 1.82 mg / Astaxanthin 12 mg with LuZeAbility capsule compared to Lutein 18.18 mg / Zeaxanthin 1.82 mg / Astaxanthin 12 mg capsuleTimepoint: 0, 1, 3, 6, 9, 12, 14, 24, 26, 36, 48, and 72 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence, severity, and relationship of adverse events (AEs). Changes in vital signs (heart rate, blood pressure, respiratory rate, and body temperature). Findings from physical examinations (PEs).Timepoint: Timepoints:0 hour, 6 hours, 9 hours, 14 hours 26 hours, 36 hours, 48 hours and 72 hours post dosing of IP;Changes from baseline in clinical laboratory parameters (hematology, biochemistry, and urinalysis).Timepoint: Timepoints: Day 0, Day 4 | — |
Countries
India
Contacts
Public ContactDr Shubarani M
Bangalore Clinical Services
Outcome results
None listed