None listed
Conditions
Interventions
Intervention1: Zeal Vitamin C: a single oral dose, 500 mg capsules of test product will be administered orally.
Control Intervention1: Vitamin C: a single oral dose, 500 mg capsules of reference produ
Sponsors
Aurea Biolabs P Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Normal, healthy, adult, male and female human subjects of age between 21-65 years with a Body Mass Index (BMI) ranges between 18.50 kg/m2 to 24.99 kg/m2 Plasma Ascorbic acid at screening Subject agrees avoid vitamin C containing medications and dietary supplements from screening until last visit. Subject agrees to avoid high activity physical exercise 72.00 hours prior to last visit Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 29 days of check in. Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance. Healthy as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous systems) and vital sign assessments. Generally healthy as documented by 12-lead electrocardiogram (ECG), X-Ray and clinical laboratory assessments.
Exclusion criteria
Exclusion criteria: Evidence of allergy or known hypersensitivity to Vitamin C or other related drugs or other related drugs. Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus, renal or liver impairment and pre-existing gallbladder disease. Any major illness in the last three months or any significant ongoing chronic medical illness. Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal, respiratory, central nervous system, diabetes, psychosis or any other body system. History of alcohol addiction or abuse. Malabsorption syndrome that affects vitamin c metabolism. Heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with >100/min ventricular rate. Gastrointestinal bleeding in past three months. Uncontrolled diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the oral bioavailability of investigational product (Zeal Vitamin C, 500 mg capsules which contains 150 mg of vitamin C) of Plant Lipids, and reference product (Vitamin C, 500 mg capsules which contains 150 mg of vitamin C and 350 mg of starch) of Plant Lipids in healthy, adult, human subjects under fasting conditions.Timepoint: 11.00 hours pre-dose to 24.00 hours post-dose and the washout period of at least 07 days from the successive dosing day. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events and to ensure the safety of the subjects.Timepoint: 11.00 hours pre-dose to 24.00 hours post-dose and the washout period of at least 07 days from the successive dosing day. | — |
Countries
India
Contacts
Public ContactDivya C
BioAgile Therapeutics Pvt Ltd
Outcome results
None listed