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Chulalongkorn Medical Journal

Abstract

Background : Phenethyl isothiocyanate (PEITC) is a dietary phytochemical with anticancerproperties. Recently, it was added to Nutri Jelly, a nutritious geldeveloped for cancer patients with eating and swallowing problems.Objectives : To evaluate pharmacokinetics, safety and tolerability of isothiocyanatesafter single- and multiple-oral administrations of 40 mg of PEITC in NutriJelly in healthy volunteers.Methods : This was an open-label, single- and multiple-dose study. Ten subjectsreceived a single dose of 40 mg of PEITC in Nutri Jelly and continued withthis dose once daily for 5 days. Serial plasma samples at various timesafter the administration on day 1 and 5 were collected to determine totalisothiocyanate levels using HPLC-based cyclocondensation assay.Single- and multiple-dose pharmacokinetics were analyzed using noncompartmentalanalysis. Safety and tolerability assessments includedphysical examination, electrocardiogram, clinical laboratory tests andadverse events.Results : After single administration, maximum concentrations of isothiocyanateswere observed at 2.65 ± 0.89 h (mean ± SD).The mean apparent volumeof distribution and oral clearance were 1.13 ± 0.91 L/kg and 22.16 ± 4.31L/h, respectively. Isothiocyanates were rapidly eliminated with the averageterminal half-life of 1.75 ± 0.93 h. After multiple-dose administration,the mean accumulation index was 1.003 ± 0.007. There was no seriousadverse event reported and no clinically significant abnormality was foundin any of the clinical and biochemical parameters.Conclusions : Nutri-PEITC Jelly was well-tolerated in healthy subjects with mild adverseevents. Total isothiocyanates were rapidly eliminated with a short half-life.No significant accumulation was observed upon repeated doses for 5 days.

Publisher

Faculty of Medicine, Chulalongkorn University

First Page

631

Last Page

643

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