Enhanced bioavailability of a novel double-layered nano-liposomal curcumin (BNT-C060): a randomized, double-blind, clinical trial.

Curcumin exhibits potent anti-inflammatory, antioxidant, and neuroprotective effects. However, its therapeutic potential is severely limited by poor oral bioavailability due to low solubility, rapid metabolism, and poor intestinal permeability. This study evaluated the single-dose pharmacokinetics and relative bioavailability of BNT-C060, a novel double-layered chitosan/alginate-coated nano-liposomal curcumin, versus conventional free curcumin in healthy male volunteers. In this randomized, double-blind, parallel-group trial, 18 healthy males (n = 9/group) received single oral doses of BNT-C060 (400 mg curcumin-equivalent) or free curcumin (2,000 mg) under fasting conditions. Plasma and urine samples were collected over 24 h for total curcumin analysis (LC-MS/MS after β-glucuronidase treatment). BNT-C060 demonstrated superior dose-normalized pharmacokinetics: 23.2-fold higher plasma AUC0-t (5.00 vs. 0.22 ng·h/mL/mg), 53-fold higher Cmax (1.06 vs. 0.02 ng/mL/mg), and 35.3-fold higher urinary exposure. Tmax was earlier (0.86 vs. 3.3 h). A single oral dose of BNT-C060 was generally well tolerated in healthy male volunteers within the evaluated dose range, with no clinically significant safety signals observed under the study conditions. BNT-C060 achieved substantially higher plasma concentrations (Cmax 423 ng/mL vs. 34 ng/mL free curcumin) compared with free curcumin, suggesting improved systemic exposure with the nano-liposomal formulation. These proof-of-concept findings provide a rationale for further clinical investigation of this advanced nano-liposomal delivery system.