None listed
Conditions
Interventions
Intervention1: Liposomal vitamin C: Stength: Each 5 ml contains 1000 mg of Vitamin C
Route: Oral
Dose: 1000 mg
Frequency: Single dose
Control Intervention1: Vitamin C (Non Liposomal): Stength: Each 5
Sponsors
CureSupport
Eligibility
Inclusion criteria
Inclusion criteria: 1. Normal, healthy, adult, male and female human subjects of age between 18-45 years with a Body Mass Index (BMI) ranges between 18.50 kg/m2 to 30.00 kg/m2 2. Subject agrees avoid Curcumin containing medications and dietary supplements from screening until last visit. 3. Subject agrees to avoid high activity physical exercise 72.00 hours prior to last visit 4. Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 29 days of check in 5. 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 6. Non- smokers or ex-smokers. Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months 7. Willing to consume ova-lacto vegetarian diet 8. Willing to comply to all requirements of this study protocol as well as instructed by the study personnel 9. Female subjects within normal limits or clinically non-significant laboratory evaluation results for FSH & LH 10. Generally healthy as documented by gynecological examination and breast examination 11. Female subjects of childbearing potential A) Practicing an acceptable non-hormonal contraceptive method of birth control after consulting with principal investigator; and/or B) Surgically sterile (bilateral tubal ligation)
Exclusion criteria
Exclusion criteria: 1. Evidence of allergy or known hypersensitivity to Vitamin C or other related drugs or other related drugs. 2. Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus, renal or liver impairment and pre-existing gallbladder disease. 3. 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. 4. History of alcohol addiction or abuse. 5. Consumption of caffeine and /or Xanthine containing products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), tobacco containing products for at least 24.00 hours prior to check-in and throughout the entire study 6. Consumption of grapefruit and its juice and poppy containing foods for at least 72.00 hours prior to check-in and throughout the study. 7. Subjects who taken any prescription medications, over the counter medicinal products, herbal medications within 14 days prior to study check in and throughout the study. 8. History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in of each period. 9. An unusual or abnormal diet within 48.00 hours prior to study check-in of each period, for whatever reason e.g. because of fasting due to religious reasons. 10. Subject who had participated in any other study within the 90 days of check-in. 11. History of difficulty in swallowing. 12. Positive results for 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. 13. Positive results for alcohol breath test prior to check-in of any study period 14. Any blood donation / excess blood loss within 90 days of check-in. 15. Systolic blood pressure less than 90mrn Hg or more than 140mmHg and diastolic blood pressure less than 60 mmHg or more than 90 mmHg. 16. Ingestion of any hormonal agent at any time within 14 days prior to start of study check-in. 17. Female subjects demonstrating a positive pregnancy screen. 18. Female subjects whose menstruation cycle coincides with the study periods. 19. Female subjects who are currently lactating. 20. Females likely to become pregnant during conducting of the study 21. Use of hormone replacement therapy for a Period of 06 months prior to dosing. 22. Use of any oral contraceptives including estrogen and progestin combined pills and progestin only pills within 28 days prior to period I dosing).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary parameters are: Cmax, AUC0-t & AUC0-infinityTimepoint: 0.00, 00.25, 00.50, 00.75, 01.00, 01.50, 02.00, 02.50, 03.00, 04.00, 05.00, 06.00, 07.00, 08.00, 09.00, 10.00, 11.00, 12.00, 14.00, 16.00 and 24.00 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| tmax, Kel, t½Timepoint: 00.00, 00.25, 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 07.00, 08.00, 09.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours | — |
Countries
India
Contacts
Public ContactDivya Chandradhar
Bio Agile Therapeutics Ltd
Outcome results
None listed