To estimate the blood concentrations of liposomal vitamin c 5ml/1000mg (test) comapared with non liposomal vitamin c 5ml/1000mg (reference) in healthy, adult, human subjects under fasting conditions

Not Applicable

Not yet recruiting

Registration Number: CTRI/2017/07/008953

Lead Sponsor: CureSupport

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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, <br/ ><br>08.00, 09.00, 10.00, 11.00, 12.00, 14.00, 16.00 and 24.00 hours

Secondary Outcome Measures

Name	Time	Method
tmax, Kel, tÂ½Timepoint: 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, <br/ ><br>08.00, 09.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours