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<p>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 (<i>n</i> = 9/group) received single oral doses of BNT–C060 (400&#xa0;mg curcumin-equivalent) or free curcumin (2,000&#xa0;mg) under fasting conditions. Plasma and urine samples were collected over 24&#xa0;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<sub>0–t</sub> (5.00 vs. 0.22 ng·h/mL/mg), 53-fold higher C<sub>max</sub> (1.06 vs. 0.02 ng/mL/mg), and 35.3-fold higher urinary exposure. T<sub>max</sub> was earlier (0.86 vs. 3.3&#xa0;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<sub>max</sub> 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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月31日

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  • Do-Sung Kim,
  • Hye Kyung Kim,
  • Ki Chan Ha,
  • Gi-Hyun Jang,
  • Se-Ho Park,
  • Do-Hyeon Kim,
  • Yu-Mi Kim,
  • Jaesung Pyo,
  • Jong-Cheon Joo,
  • Han-Jung Chae

摘要

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.