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

Abstract 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 AUC 0–t (5.00 vs. 0.22 ng·h/mL/mg), 53-fold higher C max (1.06 vs. 0.02 ng/mL/mg), and 35.3-fold higher urinary exposure. T max 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 (C max 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.