None listed
Conditions
Interventions
Intervention1: Formulated Vitamin C (F-CAS-70): Single day Oral Administration of Single dose of Formulated Vitamin C (F-CAS-70)
Control Intervention1: Unformulated Vitamin C (UF-CAS-70): Single day O
Sponsors
Akay Natural Ingredients Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects with a normal Vitamin C status 2.BMI between 18-25 kg/m2 (inclusive) 3.Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 4.Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study
Exclusion criteria
Exclusion criteria: 1.Subjects who have consumed Vitamin C containing food 2 days, prior to screening 2.History of consumption medications known to interact with Vitamin C 3.Subjects having symptoms of viral infection, including COVID-19 infection 4.Pregnant or lactating women 5. History of Irritable bowel syndrome, malabsorption or gastrointestinal abnormalities which may affect drug absorption, duodenal ulcer or gastric ulcer, gastritis, Kidney disease, kidney stones, cardiac conditions, Recent blood donation (within 1 month),Current smoker or has quit smoking within last 3months, Alcoholism and/or drug abuse, or heavy drinkers, Immunodeficiency disease (e.g., human immunodeficiency virus infection,Allergy, medication or supplement use that influences the immune system 6.Subjects with known hypersensitivity to the investigational products. 7.Subjects who have participated in any clinical trial in the past 1 month. 8.Any subjects found to have entered in to the study in violation of this protocol or if the subject is uncooperative during the study. 9.Any other condition that in the opinion of the investigator that does not justify the subjectâ??s participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| formulated Vitamin C (F-CAS-70) and unformulated Vitamin C (UF-CAS-70) concentrations in Plasma after oral administrationTimepoint: Day 1 (Period 1), Day 11 (Period 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety and tolerability of formulated Vitamin C (F-CAS-70)in comparison with unformulated Vitamin C (UF-CAS-70)supplementationTimepoint: Day 1 (Period 1), Day 11 (Period 2) | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed