None listed
Conditions
Interventions
Intervention1: Vitamin C Sustained Release Tablets: 500 Mg
Oral Dose
Single dose two period
Control Intervention1: Vitamin C Tablets: 500 Mg
Oral Dose
Single Dose Two Period
Sponsors
Nutriventia Limited
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the Oral bioavailability of Vitamin C SR Tablets 500 mg and Vitamin C Tablets 500 mg in Healthy Adult Human Subjects Under Fasting ConditionsTimepoint: -36.00 hrs -12.00 hrs -02.00 hrs 00.00 hrs 00.50 hrs 01.00 hrs 01.50 hrs 02.00 hrs 02.50 hrs 03.00 hrs 03.50 hrs 04.00 hrs 04.50 hrs 06.00 hrs 08.00 hrs 12.00 hrs 16.00 hrs 24.00 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of test and reference products in healthy Adult human subjects under Fasting conditionsTimepoint: -36.00 hrs -12.00 hrs -02.00 hrs 00.00 hrs 00.50 hrs 01.00 hrs 01.50 hrs 02.00 hrs 02.50 hrs 03.00 hrs 03.50 hrs 04.00 hrs 04.50 hrs 06.00 hrs 08.00 hrs 12.00 hrs 16.00 hrs 24.00 hrs | — |
Countries
India
Contacts
Public ContactDr Pradeep T
Spinos Lifescience and research private limited
Outcome results
None listed