An Open Label Balanced Randomized Single Dose Two Treatment Two Period Two Sequence Two Way Crossover Oral Bioavailability Study Of Vitamin C Sustained Release Sr Tablets 500 Mg

Not Applicable

Not yet recruiting

Registration Number: CTRI/2024/08/071926

Lead Sponsor: utriventia Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Normal healthy adult human subjects of age between 18 To 45 years and Body Mass Index (BMI) between 18.50 kg/m2 to 29.99 kg/m2

Subjects who have no evidence of underlying disease during screening and check in and whose screening is performed within 21 days of check in

Subjects whose screening laboratory values are within normal limits are considered by the physician or principal/clinical investigator to be of no clinical significance

Healthy as documented by the medical history physical examination including

Generally healthy as documented by a 12 lead electrocardiogram ECG Chest X Ray and clinical laboratory assessments

Willing to consume ovo lacto vegetarian diet

Willing to comply with all requirements of this study protocol as well as instructions from the study personnel

Subject is willing to abstain from all vitamin C rich foods fruits for at least 07 days prior to check in and throughout the study

Non smokers or ex smokers

Ex smokers are defined as someone who has completely stopped smoking for at least the past 03 months

Exclusion Criteria

Evidence of allergy or known hypersensitivity to Vitamin C or its supplements

Subjects with hepatic encephalopathy cholestasis myasthenia pre existing liver diseas, alcohol abuse existing tinnitus and pre existing gallbladder disease

Any major illness in the last three months or any significant ongoing chronic medical illness

Renal or liver impairment

Any disease or condition that might compromise the haemopoeitic gastrointestinal renal, hepatic cardiovascular Musculoskeletal respiratory central nervous system or any other body system including presence of Diabetes Mellitus and Psychosis

History of alcohol addiction or abuse

Consumption of caffeine and /or xanthine containing products (i.e. coffee, tea, chocolate caffeine containing sodas, colas, etc) cigarettes and tobacco containing products for at least 48.00 hours prior to check in and throughout the entire study

Consumption of alcohol and its products, grapefruit and/ or its juice and poppy containing foods within 48.00 hours prior to clinic admission and throughout the entire study

Subjects who have taken any prescription medications within 14 days prior to study check in and throughout the study or any supplements containing Vitamin C within 07 days prior to study check in and throughout the study and any over the counter medicinal products herbal medications within 15 days prior check-in of period I till end of the study

Subjects who have consumed an unusual diet for whatever reason (e.g. low salt) for 48.00 hours prior to dosing and throughout the study

Subject who had participated in any other study within the 90 days of check in

History of difficulty in swallowing

History of difficulty in accessibility of veins

Positive results for urine screen of drugs of abuse (Marijuana THC amphetamine AMP barbiturates BAR cocaine COC benzodiazepines BZD and morphine MOR) in urine prior to check-in of this study period

Positive results for alcohol test prior to check-in of each period

Any blood donation / excess blood loss within 90 days of check-in