An open label randomised, single dose two treatment two way crossover oral bioavailability study of investigational product in healthy adult human participant under fasting conditions.
- Registration Number
- CTRI/2023/07/055382
- Lead Sponsor
- YourZooki holdings Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
Normal healthy adult male and female Human participants of age between 21-65 years with a Body Mass Index (BMI) range between 18.50 kg/m2 to 24.99 kg/m2.
2.Plasma Ascorbic acid at screening <75µmol/1.
3.Subject agrees avoid vitamin C containing medications and dietary supplements from screening until last visit.
4.Subject agrees to avoid high activity physical exercise 72.00 hours prior to last visit
5.Subjects who have no evidence of underlying disease during screening and check- in and whose screening is performed within 29 days of check in.
6.Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance.
7.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.
8.Generally healthy as documented by 12-lead electrocardiogram (ECG), X-Ray and clinical laboratory assessments.
9.Non- smokers or ex-smokers. Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months.
10.Willing to consume ova-lacto vegetarian diet.
11.Willing to comply to all requirements of this study protocol as well as instructed by the study personnel
12.Female subjects within normal limits or clinically non-significant laboratory evaluation results for FSH and LH.
13.Generally healthy as documented by gynecological examination and breast examination (for female subjects during Period-I check-in only).
14.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)
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.
4.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.
5.History of alcohol addiction or abuse.
6.Malabsorption syndrome that affects vitamin c metabolism.
7.Heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with >100/min ventricular rate.
8.Gastrointestinal bleeding in past three months.
9.Uncontrolled diabetes mellitus.
10.Active psychiatric disorder, intention for suicidal, disorders with Unconsciousness.
11.Psychopathic disorder, lack of cooperation.
12.Chronic obstructive lung disease or active smoking (more than 2 cigarettes in the past 6 months)
13.Taking more than 100 mg vitamin C daily within 2 weeks to screening.
14.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
15.Consumption of grapefruit and its juice and poppy containing foods for at least 72.00 hours prior to check-in and throughout the study.
16.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.
17.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.
18.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.
19.Subject who had participated in any other study within the 90 days of check-in.
20.History of difficulty in swallowing.
21.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.
22.Positive results for alcohol breath test prior to check-in of any study period
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax AUC0-t AUC0-infinity.Timepoint: pre-dose blood sample 00.00 hours 05 ml will be collected within 60 minutes prior to dosing. Post dose blood samples 05 ml will be collected at 00.50, 01.00, 02.00, 06.00,12.00 ,24.00 & 48 hours.
- Secondary Outcome Measures
Name Time Method tmax, Kel, t½.Timepoint: pre-dose blood sample 00.00 hours 05 ml will be collected within 60 minutes prior to dosing. Post dose blood samples 05 ml will be collected at 00.50, 01.00, 02.00, 06.00,12.00 ,24.00 & 48 hours.