A CROSSOVER, ORAL BIOAVAILABILITY STUDY OF INVESTIGATIONAL PRODUCT (ZEAL VITAMIN C) OF PLANT LIPIDS, AND REFERENCE PRODUCT (VITAMIN C) OF PLANT LIPIDS IN HEALTHY, ADULT, HUMAN SUBJECTS UNDER FASTING CONDITIONS.

Not Applicable

• Registration Number: CTRI/2019/07/020159
• Lead Sponsor: Aurea Biolabs P Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 <75μmol/1

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

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.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified