None listed
Conditions
Interventions
Intervention1: F-DV-2000: Single day Oral Administration of Single dose of F-DV-2000
Intervention2: F-DV -5000: Single day Oral Administration of Single dose of F-DV -5000
Control Intervention1: UF-DV
Sponsors
Akay Natural Ingredients Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects with a normal Vitamin D status 2.Subjects with 25-OH vitamin D3 status in between 20-30ng/mL at the baseline. 3.BMI between 19-26 kg/m2 (inclusive) 4.Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 5.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 D3 supplements within 3 weeks prior to the screening. 2.Subjects having symptoms of viral infection, including COVID-19 infection 3.Subjects with known hypersensitivity to the investigational products 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 who have participated in any clinical trial in the past 1 month. 7.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 |
|---|---|
| Concentrations of Vitamin D in the PlasmaTimepoint: Day 1 (Period 1), Day 22 (Period 2) Day 43 (Period 3) Day 64 (Period 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Over all Safety Of the study based on AEs and SAEsTimepoint: Day 1 (Period 1), Day 22 (Period 2) Day 43 (Period 3) Day 64 (Period 4) | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio services Pvt. Ltd.
Outcome results
None listed