A comparative Clinical study to assess the bioavailability of FIL-Vitamin C formulation in healthy volunteers.

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Subjects with Body mass index (BMI) of 18-25 kg/m2.

2.Subjects who are willing to give their written informed consent to participate in the study and comply with the protocol requirements.

3.Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening.

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.

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 3 months.

•Alcoholism and/or drug abuse, or heavy drinkers.

•Immunodeficiency disease.

•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 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 subject’s participation in the trial.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To estimate the plasma concentrations of Vitamin C following supplementation of FIL-Vitamin C and/or unformulated Vitamin C, in healthy volunteers.Timepoint: Pre-dose sample, Post-dose sample at 30 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8hours & 12 hours

Secondary Outcome Measures

Name	Time	Method
The safety & tolerability of FIL-Vitamin C Formulations <br/ ><br>Timepoint: Pre-dose sample, Post-dose sample at 30 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8hours & 12 hours