A comparative pharmacokinetic evaluation of bioavailable curcumin formulation Curene® with curcumin formulation containing turmeric volatile oil and standard curcuminoids 95% in healthy human subjects

Abstract

Background: Curcumin, a major active component of turmeric, is one of the most studied botanicals for its numerous health benefits and high safety profile. In spite of its potential clinical health benefits, its applications are limited due to its poor bioavailability. The current study was carried out to compare the oral bioavailability of the newly developed bioavailable curcumin formulation Curene® with a curcumin formulation containing turmeric volatile oil (CP-01) and standard curcuminoids 95% in healthy human volunteers. Methods: In this current open-label, randomized, three-treatment, single oral dose, single-period, parallel, comparative pharmacokinetics study, 12 healthy male volunteers participated. The test product Curene® (test treatment - T), reference products CP-01 (reference treatment - R1) and standard curcuminoids 95% (reference treatment - R2) were orally administered as a single dose of 3 grams per subject. Plasma samples were withdrawn from each subject at predetermined time points, and samples were analyzed by LC-MS/MS. Results: Based on the pharmacokinetics data, Curene® (Free curcumin; AUC0-t) was found to be ~112.7 times more relatively bioavailable when compared to the standard curcuminoids (R2). Conclusion: The oral bioavailability of Curene® was found to be significantly higher compared to CP-01 and standard curcuminoids (95%). Furthermore, Curene® was also found to be safe in healthy human subjects under the study conditions.