None listed
Conditions
Interventions
Intervention1: DELT Vitamin C: Oral administration of a single dose of DELT Vitamin C capsule
Control Intervention1: Conventional Vitamin C: Oral administration of a single dose of Conventional Vitami
Sponsors
Encapscifi Lifesciences Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject who agree not to consume any vitamin C based foods throughout the study. 2. Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening. 3. 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 either Vitamin C containing food/supplement 7 days prior to screening. 2.Pregnant or lactating women. 3.Subjects with known hypersensitivity to the investigational products. 4.Subjects who have participated in any clinical trial in the past 1 month. 5.Any subjects found to have entered in to the study in violation of this protocol or if the subject is uncooperative during the study. 6.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 concentrations of vitamin C in DELT vitamin C in comparison with conventional vitamin C and plain vitamin C supplementation.Timepoint: Period 1, Period 2, Period 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics parameters of DELT vitamin C in comparison with conventional vitamin C and plain vitamin C.Timepoint: Baseline, Day 9, Day 17;Safety and tolerability of DELT vitamin C in comparison with conventional vitamin C and plain vitamin C.Timepoint: Baseline, Day 9, Day 17 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed