None listed
Conditions
Interventions
Intervention1: 011W (Amaranthus extract): 2g of powder in screw cap plastic vial.
Dosage will be 1 vial per period. Total 4 periods.
Administration: All the powder in the vial will be emptied into a g
Sponsors
Arjuna Natural Ltd Formerly Arjuna Natural Extracts Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy, adult, human subject aged from 18 to 55years. 2. Subjectâ??s Body Mass Index (BMI) within normal limit of 18.5-30kg/m2. 3. Willingness to sign statements of written informed consent form (for screening & study related procedures). 4. No contraindications with the study medication with any previous medical or surgical history. 5. Willingness to undergo pre- and post-study physical examinations and laboratory investigations. 6. Normal general physical examination& vitals. 7. Availability of subject for the entire study period and willingness to adhere to protocol. 8. Non- smokers and Non- alcoholics.
Exclusion criteria
Exclusion criteria: 1. Subjects incapable of understanding the informed consent process/procedure. 2. Subjects who have participated in any clinical trials within 6 months or donated blood greater than 300 mL in the past 3 months. 3. Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study, or limit the ability to comply with protocol requirements. 4. The subject with known history of clinically significant psychiatric or medical diseases will be excluded from the study. 5. Resting heart rate of greater than 100 beats/min or less than 60 beats/min on the screening day. 6. History of hypotensive episodes, or systolic blood pressure reading of less than 100 mmHg or a diastolic reading of less than 60 mmHg at time of general Physical examination. 7. History of hypertension, or systolic blood pressure reading of greater than 140 mmHg or a diastolic reading greater than 90 mmHg at time of general Physical examination. 8. The subject has any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations. 9. Subject who have taken any enzyme modifying medications within the past four weeks prior to start of clinical period. 10. Subject who have taken any prescribed medications beginning two weeks prior to and OTC medications beginning one week prior to first dosing of study. 11. The subject with known hypersensitivity or idiosyncratic reaction to Nitrate containing supplements or foods containing nitrates. . 12. History of or current alcohol abuse (greater than 600 mL weekly) or history of exposure to other substance of abuse. 13. Subject found positive for alcohol breath test. 14. Investigations with blood samples of the subject shows presence of disease marker of HIV 1 and 2, Hepatitis B & C viruses. 15. Investigations with blood sample of the subjects, shows the presence of values which are clinically significantly different from normal reference range. 16. Investigations with urine sample of the subject shows clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC, epithelial cells, glucose (positive) and protein (positive) (unless the investigator considers the deviation to be irrelevant for the purpose of the study). 17. Xanthine-containing food or beverages (tea, coffee, chocolates, soft drinks like cola etc.) within 24 hours prior to the dosing of each period or alcoholic products consumption within 48 hours prior to the dosing of each period. 18. Subjects who have consumed â??Grape fruitâ?? or its juice within 72 hours prior to dosing of each period. 19. Consumption of food containing nitrate like Red/green spinach, Lettuce, Beetroot, Celery, legumes and packed foods contain nitrate or nitrite preservatives like tinned seafood or bacon. Subject without adequate venous access in their left or right arm to allow collection of all samples via venous cannula in each period of the study. 20. X-ray chest finding suggesting of any abnormality/ies like cardiomegaly, pneumonia etc. 21. Subject with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and /or renal function, that could interfere with the absorption, metabolism, and /or excretion of the study IPs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of oral bioavailability of nitrates & nitrites in the blood plasma and saliva after intake of the three extracts of Amaranthus. Timepoint: Pre-dose 0 hour, at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 16 and 24 hours post-dose respectively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of bioequivalence of the three extracts of Amaranthus.Timepoint: Pre-dose 0 hour, at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 16 and 24 hours post-dose respectively. | — |
Countries
India
Contacts
Public ContactDr Binu T Kuruvilla
Arjuna Natural Limited
Outcome results
None listed