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Purpose This phase I study was performed in volunteers of Japanese ethnicity to compare pharmacokinetic data after infusion of 6% hydroxyethyl starch (HES) 130/0.4 with historical data of Caucasians. Methods In an open-label, uncontrolled, single-center study, 12 healthy male Japanese volunteers received single intravenous infusions of 500 ml 6% HES 130/0.4 (Voluven 6%; Fresenius Kabi Deutschland, Bad Homburg, Germany) over 30 min. Results Plasma concentration of 6% HES 130/0.4 was highest at end of infusion (5.53 ± 0.55 mg/ml) and decreased following a biphasic manner. Total plasma clearance and rapid and slow elimination half-lives obtained by a two-compartment model were 1.14 ± 0.16 l/ h, 1.12 ± 0.26 h, and 9.98 ± 2.38 h, respectively, and the volume of distribution was 4.76 ± 0.64 l. Mean area under the concentration-time curve was 26.7 ± 3.75 mg/ml h. The total amount of HES excreted into urine was 59.4% of the applied dose. Hemodilution was observed in all 12 subjects as indicated by a decrease of hemoglobin from 15.5 ± 0.4 g/dl at baseline to 13.8 ± 0.4 g/dl after the end of infusion. Adverse events in this study refer to changes of laboratory parameters and were assessed as not clinically relevant. Conclusion Single administration of a 500 ml solution of 6% HES 130/0.4 was confirmed to be safe and tolerable in healthy male Japanese subjects. A rapid renal excretion was observed within 24 h after drug administration, accounting for 96% of the total amount excreted. A comparison with pharmacokinetic data derived from Caucasians did not reveal significant differences to Japanese and confirmed the good tolerability in both ethnic groups. Keywords Hydroxyethyl starch * 6% HES 130/0.4 * Pharmacokinetics * Safety * Japanese healthy male volunteers, Introduction Hydroxyethyl starch (HES) solutions are used in most parts of the world to maintain circulating blood volume (normovolemia) or to treat hypovolemia according to the individual need of the [...]