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

A randomized, single-dose, double-blind, active-controlled, two-way crossover study to assess the oral bioavailability of FIL-Vitamin C in healthy volunteers. - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057212

Enrollment

Registered

2023-09-01

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: FIL-Vitamin C: Oral administration of single dose of formulated Vitamin C 600mg capsule Control Intervention1: Unformulated Vitamin C: Oral administration of single dose of unformulated

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
The safety & tolerability of FIL-Vitamin C Formulations 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	—

Countries

India

Contacts

Public ContactJestin V Thomas

Leads Clinical Research and Bio Services Pvt. Ltd

jestinleadsclinbio@gmail.com9845125293

Outcome results