Clinical Drug Investigation

, Volume 16, Issue 2, pp 151-160

First online:

Pharmacokinetics and Tolerability of a New Hydroxyethyl Starch (HES) Specification [HES (130/0.4] after Single-Dose Infusion of 6% or 10% Solutions in Healthy Volunteers

  • Josef WaitzingerAffiliated withL.A.B. GmbH & Co Email author 
  • , Frank BepperlingAffiliated withFRESENIUS AG Pharmaceuticals Division
  • , Günther PabstAffiliated withL.A.B. GmbH & Co
  • , Jens OpitzAffiliated withFRESENIUS AG Pharmaceuticals Division
  • , Margarete MüllerAffiliated withL.A.B. GmbH & Co
  • , Jean François BaronAffiliated withDépartment d’Anesthésie-Réanimation, Hôpital Broussais

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Objective: To investigate the pharmacokinetic profile and tolerability of a single-dose infusion of the new hydroxyethyl starch (HES) specification, HES (130/0.4), 6% and 10% solutions in healthy volunteers.

Study Design: In an open, randomised, single-dose, parallel-group study, 12 healthy volunteers (in each group) received intravenous infusions of 500ml of a new HES specification [HES (130/0.4)] of either 6% or 10% solution within 30 minutes.

Results: Plasma elimination initially occurred with an α half-life of approximately 0.5 to 0.75 hour. A half-life of approximately 12 hours was reported for the terminal phase. Between 60 to 70% of the total plasma elimination was due to renal excretion. The total plasma clearances of 31.4 ml/min and 26.0 ml/min for the 6 and 10% solutions, respectively, were higher than those reported for other HES specifications. The volume of distribution in the central compartment was approximately 5.9L, which roughly corresponded to the blood volume. Single doses of 6% and 10% HES (130/0.4) were well tolerated.

Conclusion: The new HES specification demonstrated favourable pharmacokinetic properties compared with other HES specifications of medium or high molecular weight. No clinically relevant plasma accumulation and related undesired effects on haemostasis are expected to occur under multiple-dose conditions.