A Comparative Pharmacokinetic Evaluation of a 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, which is one of the most studied botanicals for its numerous health benefits and higher safety profile. In spite of its potent clinical health benefits, its applications are circumscribed due to its poor bioavailability. The current study was carried out to compare the oral bioavailbility of newly developed bioavailable curcumin formulation Curene^® with Curcumin formulation containing turmeric volatile oil (CP-01) and Standard Curcuminoids 95% in healthy human volunteers.

Methods: In this current open-label, randomized, three treatments, single oral dose, single period, parallel, comparative pharmacokinetics study, 12 healthy male volunteers participated. The test product Curene^® (T), reference products CP-01(Reference treatment-R₁) and Standard Curcuminoids 95% (Reference treatment-R₂) were orally administrated as a single dose of 3 grams per subject. Plasma samples were withdrawn from each subject at predetermined timepoints and samples were analyzed by LC-MS/MS. 

Results: Based on the pharmacokinetics data, the relative bioavailability (Free Curcumin; AUC_0-t) of Curene^® was found to be ~112.7 times more when compared to the standard Curcuminoids (R₂).

Conclusion: The oral bioavailability of Curene^® was found to be significantly higher compared to CP-01and Standard Curcuminoids (95%) furthermore, it was also found to be safe in healthy human subjects under the study conditions.