Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Storka, A; Vcelar, B; Klickovic, U; Gouya, G; Weisshaar, S; Aschauer, S; Bolger, G; Helson, L; Wolzt, M.
Safety, tolerability and pharmacokinetics of liposomal curcumin in healthy humans.
Int J Clin Pharmacol Ther. 2015; 53(1): 54-65.
Doi: 10.5414/CP202076
Web of Science
PubMed
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- Co-authors Med Uni Graz
- Klickovic Uros
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- Abstract:
- INTRODUCTION: Experimental studies have shown that liposomal curcumin can exert a reduction in tumor growth in pancreatic and colorectal cancer. In this phase I clinical trial we investigated the pharmacokinetics, safety, and tolerability of intravenously administered liposomal curcumin in healthy subjects. MATERIAL AND METHODS: 50 male and female participants were included in this randomized, placebo-controlled double-blind phase I dose escalation study. Subjects received a single dose of liposomal curcumin (10 - 400 mg/m2; n = 2 - 6 per group) or placebo over 2 hours intravenously. RESULTS: Dose-dependent increases in the plasma concentrations of curcumin and its metabolite tetrahydrocurcumin (THC) were detected. After the end of drug infusion, curcumin and THC plasma concentrations decreased within 6 - 60 minutes below the limit of quantification. Mean urinary excretion was ~ 0.1% of total systemic clearance. Liposomal curcumin was tolerated well, but a transient red blood cell echinocyte formation with concomitant increase in mean cellular volume was observed at dosages ≥ 120 mg/m2. CONCLUSION: Short-term intravenous dosing of liposomal curcumin appears to be safe up to a dose of 120 mg/m2. Changes in red blood cell morphology may represent a dose limiting sign of toxicity.
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- Female - administration & dosage
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- Find related publications in this database (Keywords)
- liposomal curcumin
- human
- pharmacokinetics
- red blood cells