The sponsor has developed new curcuminoid formulations with the expectation of enhanced bioavailability compared to existing benchmark products. This study aims to evaluate the comparative bioavailability and characterize the pharmacokinetic profile of the test formulations in comparison to the reference formulations in healthy adult subjects under fasting conditions.
9.5.1 Able and willing to participate in the study by complying with the protocol procedures as evidenced by a dated and signed informed consent form 9.5.2 Age greater than equal to 18 less than equal to 45 years. 9.5.3 Willing to consume the study product and donate blood. 9.5.4 BMI from 18.5 to 29.9 kg/m². 9.5.5 Subject with normal health as determined by personal medical and medication history, clinical examination and laboratory examinations within the clinically acceptable limits.
9.6.1 Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract or may affect absorption of IP and blood forming organ.
Crossover
Curcumin Dispersome formulation
Other intervention75% BLG (600 mg (2 capsules of 300 mg each, containing 90 mg curcumin per capsule
Non-formulated Curcumin
Other interventiondose: 90 mg, 1 capsule
Benchmark Formulation 1 - Turmipure Gold™
Other interventionrecommended daily dose: 300 mg, 1 capsule
Benchmark Formulation 2 - Qunol, Turmeric, Curcumin Complex, Extra Strength
Other interventionrecommended daily dose: 1000 mg, 2 capsules of 500 mg each
Plasma Concentration of investigational products when compared with benchmark products, for Comparative Bioavailability Assessment (Cmax, AUC) under Fasting Conditions.
To assess the comparative bioavailability of investigational products versus benchmark products by evaluating pharmacokinetic parameters including maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC), in healthy adult subjects under fasting conditions.
Number of Participants With safety and tolerability of the product after Administration of Curcumin
The safety and tolerability of Curcumin will be evaluated by monitoring and recording, including physical examination findings, clinical laboratory results, vital signs, and participant-reported symptoms, following administration under fasting conditions.
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