None listed
Conditions
Interventions
None listed
Sponsors
India Glycols Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers within the age range of 18 to 45 years (both inclusive). 2. Presently non-tobacco users (smokers and chewers). 3. Willingness to provide written informed consent to participate in the study. 4. Body-mass index (BMI) between 18.50 kg/m2 and 29.99 kg/m2 (both inclusive) with body weight not less than 50 kg (for males) and with body weight not less than 45 kg (for females). 5. Absence of significant disease or clinically significant laboratory values or laboratory evaluation, medical history or physical examination during the screening. 6. Have a normal 12-lead ECG or one with abnormality considered to be clinically insignificant. 7. Have a normal chest X-ray PA view or one with abnormality considered to be clinically insignificant. 8. Willing to take turmeric free food for the entire study duration. 9. Comprehension of the nature and purpose of the study and compliance with the requirement of the distributed ICF. 10. Volunteer is regularly menstruating / Volunteer is in postmenopausal phase for at least 1 year / is surgically sterile (for females). 11. Volunteer of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s) such as condoms, foams, jellies, diaphragm, and intrauterine device (IUD) or abstinence etc. except hormonal contraceptives (for females).
Exclusion criteria
Exclusion criteria: 1. Personal history of allergy or hypersensitivity to Curcumin or to any components of the formulation or allied drugs or excipients. 2. Any major illness in the past 90 days or any clinically significant ongoing chronic medical illness e.g. Congestive Cardiac Failure, Hepatitis, Hypotensive episodes, Hyperglycemia etc. 3. Presence of any clinically significant abnormal laboratory values during screening e.g. significant abnormality of liver function test, renal function test etc. 4. Severe cardiac, renal or liver impairment, gastro-intestinal disease or other conditions, any other organ or system impairment. 5. History of seizures, epilepsy or any kind of Neurological disorders. 6. History of hypercalcemia or vitamin D toxicity. 7. Past history of Anaphylaxis or angioedema. 8. Presence of disease markers of HIV or Hepatitis B or Hepatitis C virus. 9. History of chronic consumption of any kind of alcoholic beverages for more than 2 years or having consumed alcohol within 48 hours prior to check-in. 10. Consumption of products containing xanthine derivatives (chocolates, tea, coffee or cola drinks) or tobacco products within 48 hours prior to check-in. 11. Consumption of grapefruit or grapefruit containing products or any cruciferous vegetables (eg. broccoli, brussels sprouts, etc.) or char-broiled meat prior 7 days of investigational product administration. 12. Use of any recreational drug or a history of drug addiction. 13. Participation in any clinical trial within the past 90 days. 14. History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm. 15. Donation of blood (one unit or 350 mL) within 90 days prior to receiving the first dose of study medication. 16. Consumption of any other prescription drug or over the counter (OTC) drugs (including vitamins and medicinal products from natural origin) within two weeks prior to receiving the first dose of study medication or repeated use of drugs within the last four weeks and throughout subject’s participation in the study. 17. An unusual diet for whatever reason e.g. low sodium diet, for two weeks prior to receiving any medication and throughout subject’s participation in the study. 18. Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 48 hours prior to the study. 19. Use of oral contraceptive in last 90 days (for females). 20. Pregnant / lactating volunteers (for females).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of Cmax, Tmax, AUC and T1/2 of test formulation (Maxicuma capsule) in comparison to that of Reference formulation (95% curcuminoid capsule)Timepoint: Primary outcome parameters will be analyzed and calculated after 24 h post dose in both phase of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: To monitor the safety and tolerability of Three Capsules as single oral dose of Maxicuma 500 mg Capsule and 95% Curcuminoid 500 mg Capsules when administered in healthy, adult, human subjects under fasting condition.Timepoint: Secondary outcome parameters will be analyzed and calculated after 24 h post dose in both phase of study. | — |
Countries
India
Contacts
Public ContactDr Rina Gokani
Accuprec Research Labs Pvt Ltd
Outcome results
None listed