None listed
Conditions
Interventions
Intervention1: Formulation 1
(CCN): 2 capsules, each containing 100 mg of turmeric rhizome dry extract (Curcuma longa), equivalent to a total of 179 mg of curcumin.
Intervention2: Formulation 2
(ES163
additionally,
containing 100 mg of Boswellia serrata extract and 3 g of cholecalciferol (Vitamin D).
Intervention6: Formulation 6
(CDF): 2 capsules, each containing 140 mg (280 mg) of turmeric rhizom
additionally, containing total 620 mg of black sesame seed oil(Sesamum indicum) and 100 mg of Boswellia serrata extract.
Intervention7: Formulation 7
(CCLP): 1 cap containing 230 mg liposomal curcumin
Sponsors
Tilman SA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male and female human participants aged between 18 and 55 years (both inclusive). 2. Participants with a BMI between 20.0-27.0 Kg/m2. 3. Participant should avoid food containing curcumin, black pepper at least 48 hrs before dosing. 4. Absence of disease markers of HIV 1 & 2, hepatitis B & C virus. 5. Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history, physical examination and systemic examination during the screening. 6. Participants having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording. 7. Participants must have stable weight (weight change less than 3 kg during last 6 months). 8. Participants willing to adhere to the protocol requirements as evidenced by written informed consent approved by the ethics committee. 9. Participants able to communicate effectively and provide written informed consent. 10. Subject is a non-smoker and non-alcoholic. 11. Female participants must have a negative urine pregnancy test prior to the housing. 12. Females of childbearing potential agreeing to use appropriate contraceptive measures like non-hormonal intrauterine devices, barrier methods, and spermicidal agents during the study and 07 days after completion of the study.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to curcumin and its metabolites. 2. Incapable of understanding the informed consent information. 3. Clinically significant medical condition, such as, but not limited to, cardiovascular, neurological, psychiatric, pulmonary, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease), or uncontrolled haematological abnormalities. 4. Any treatment which could bring about induction or inhibition of the hepatic microsomal enzyme system within one month of starting the study. 5. History or presence of alcoholism or drug abuse. 6. History or presence of asthma, urticaria, or other allergic reactions. 7. History or presence of gastric and/or duodenal ulceration. 8. History or presence of thyroid disease, adrenal dysfunction, or organic intracranial lesion. 9. History or presence of cancer. 10. Use of any prescribed medication (including herbal remedies) during the two weeks before the start of the study or OTC medicinal products (including herbal remedies) during the week before study initiation and throughout the study. 11. Participation in aerobic exercise more than three times per week. 12. Habit of consuming high caffeine (more than 5 cups of coffee or tea/day) consumption. 13. History of difficulty with donating blood or difficulty in accessibility of veins. 14. Participation in a clinical research study within the past 90 days prior to check in. 15. Use of supplements containing curcumin or its metabolites 30 days prior to dosing and during the study duration. 16. consumption of food and beverages containing xanthine (chocolates, tea, coffee, or cola drinks) for at least 48 h prior to check-in of each period. 17. consumption of grapefruit and grapefruit-like citrus fruit (mosumbi/sweet lime) or juice within the 7 days prior to check-in of each period. 18. positive results for drugs of abuse (benzodiazepines, opioids, amphetamines, cannabinoids, cocaine, and barbiturates) in urine during the check-in of each period. 19. Females who have used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 07 days before dosing. 20. Pregnant women and nursing mothers. 21. Male and females of childbearing potential unwilling to employ appropriate and reliable methods of contraception during the study till 07 days after the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma Pharmacokinetic parameters: like Cmax, Tmax, AUC0-t, AUC0-infinity, t1/2, and Kel will be calculated from the concentration Vs. time data for each formulation.Timepoint: Plasma Pharmacokinetic parameters: like Cmax, Tmax, AUC0-t, AUC0-infinity, t1/2, and Kel will be calculated from the concentration Vs. time data for each formulation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. vital signs and clinical examinations 2. ECG 3. Clinical laboratory testing [haematology (CBC), lipid profile, random blood sugar (RBS), renal function test (RFT), liver function test (LFT), electrolytes] and urinalysis. 4. Serological markers including Hepatitis B surface antigen (HBsAg), AntiHepatitis C virus (Anti-HCV), Human Immunodeficiency Virus (HIV-1 & HIV-2 antibodies). 5. Adverse events, serious adverse events. 6. Tolerability of the investigational productTimepoint: From Screening to End of the study | — |
Countries
India
Contacts
Public ContactDr Ram Mundhe
Gunjkar Multispeciality Hospital
Outcome results
None listed