A study to evaluate the bioavailability of curcumin formulations in healthy adults.

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: 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 (ES163‐1): 2 capsules, each containing 120 mg (total 240 mg) of turmeric rhizome dry extract (Curcuma longa), equivalent to a total of 200 mg of curcumin. Intervention3: Formulation 3 (ES163‐2): 2 capsules, each containing 120 mg (total 240 mg) of turmeric rhizome dry extract (Curcuma longa), equivalent to a total of 200 mg of curcumin. Intervention4: Formulation 4 (CCNF): 3 capsules, each containing 54 mg (total 161 mg) of turmeric rhizome dry extract (Curcuma longa), equivalent to a total of 129 mg of curcumin. Intervention5: Formulation 5 (FFF): 1 tablet containing 237 mg of turmeric rhizome extract (Curcuma longa), equivalent to a total of 200 mg of curcumin; 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 rhizome extract (Curcuma longa), equivalent to a total of 266 mg of curcuminoids; 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 equivalent to 110 mg of curcuminoid Control Intervention1: NIL: NIL CONDITION: PRIMARY OUTCOME: 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 OUTCOME: 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 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 effectivel
Epistemonikos ID: 32cddf5351214e4b76abf4cbcc25f737759a53a4
First added on: May 09, 2026