None listed
Conditions
Interventions
Intervention1: Liposomal Vitamin C 704.2 mg (2 capsules X 352.1 mg) [500 mg
Vitamin C + (204.2 mg Rice bran wax and sunflower lecithin)]
supplied by Wooree Green Science Co., Ltd., South Korea.: Route
Sponsors
Wooree Green Science Co., Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18-45, weight at least 50 kg 2. Informed consent and willingness to comply 3. BMI 18.50-30.00 Kg/m² 4. Overall good health 5. Absence of significant diseases 6. Normal biochemical and hematological parameters 7. Negative tests for HIV, Hepatitis, and VDRL 8. Negative drug and alcohol tests 9. Non-smoker 10. Ability to fast and consume meals as required 11. Proof of identity For Female Volunteers: 12. Negative pregnancy tests 13. Not pregnant, lactating, or attempting pregnancy 14. Use of contraception if sexually active and of childbearing potential
Exclusion criteria
Exclusion criteria: 1. Significant medical disorders 2. Major surgery within the past 3 months 3. History of dialysis 4. Various significant health conditions 5. Diabetes, tuberculosis, systemic hypertension 6. Use of certain medications 7. Recent dehydration 8. Dysphasia 9. History or presence of cancer 10. Difficulty in blood donation 11. Personal or family history of muscular disorders 12. Deformities affecting venous access 13. Significant medical disorders (repeated) 14. Recent alcohol consumption or habituation 15. Habituation to caffeine-containing products 16. Recent caffeine or xanthine product consumption 17. Recent tobacco use 18. Recent consumption of certain foods and beverages 19. Positive tests for alcohol or drug abuse 20. History of drug abuse 21. Allergies to certain substances 22. Use of medications affecting study drugs 23. Recent participation in drug studies or blood donation 24. Positive screening tests for infectious diseases 25. Recent use of over-the-counter or herbal medications 26. Recent use of prescription medications affecting study drugs 27. Unusual diets 28. Depot injections or implants of drugs 29. Practicing a vegan diet 30. Hypersensitivity to study medications 31. History or presence of certain kidney conditions 32. History or presence of Glucose-6-Phosphate Dehydrogenase Deficiency For Female Volunteers: 33. Pregnancy, lactation, or plans for pregnancy 34. Positive pregnancy tests
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the comparative bioavailability of Investigational products (Liposomal Vitamin C and Normal Vitamin C) and to understand the effect of the manufacturing process on the bioavailability of Vitamin C in normal healthy adult human subjects under fasting conditions.Timepoint: -01.00, -00.50 and 00.00 (within15 minutes) hours prior to dosing and the post dose blood samples will be collected at 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 07.00, 08.00, 10.00, 12.00 and 24.00 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of a single oral dose administered in Healthy, Adult, Human Subjects Under Fasting Conditions.Timepoint: Medical Examination will be done during screening, at the time of check-in and check-out. Vitals monitoring will be done at screening, check-in, check-out, drug administration and at 01.00, 03.00, 06.00 and 12.00 hours post dose. Post Study safety sample will collected to assess the safety of subjects at the end of the study. | — |
Countries
India
Contacts
Public ContactDr AV Krishna Raju
Laila Nutraceuticals
Outcome results
None listed