A novel amorphous preparation improved curcumin bioavailability in healthy volunteers: A single-dose, double-blind, two-way crossover study

[Display omitted] •curcuRougeTM is a micro amorphous curcumin formulation with light red color.•The bioavailability of curcuRougeTM was 3.7-fold higher than that of Theracurmin® in rats.•The bioavailability of curcuRougeTM was 3.4-fold higher than that of Theracurmin® in twelve healthy volunteers.•curcuRougeTM achieved Cmax in a shorter time than Theracurmin® in rats and humans. Curcumin derived from Curcuma longa has beneficial pharmacological effects. However, its bioavailability is very low. To improve its bioavailability, we developed a novel amorphous formulation of curcumin, called curcuRougeTM. We investigated the bioavailability of curcuRougeTM and compared its efficiency with that of Theracurmin®. Male Sprague–Dawley rats were orally administered curcuRougeTM or Theracurmin® (10 mg/kg of curcumin). Based on the area under the plasma concentration-time curve, the bioavailability of curcuRougeTM was 3.7-fold higher than that of Theracurmin® in rats. We performed a single-dose, double-blind, two-way crossover study to compare the bioavailability of curcuRougeTM and Theracurmin® (90 mg of curcumin) in 12 volunteers (8 males, 4 females). The bioavailability of curcuRougeTM was 3.4-fold higher than that of Theracurmin®. curcuRougeTM achieved Cmax in a shorter time than Theracurmin® in both experiments. These findings indicate that curcuRougeTM, an amorphous formulation of curcumin, shows superior bioavailability to that of Theracurmin®.