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01-07-2007 | Original Research Article

Bioequivalence Comparison between Hydroxyethyl Starch 130/0.42/6 : 1 and Hydroxyethyl Starch 130/0.4/9 : 1

Authors: Dr G. Lehmann, G. Marx, H. Förster

Published in: Drugs in R&D | Issue 4/2007

Abstract

Objective: The aim of this study was to investigate whether a recently developed low molecular, low substituted hydroxyethyl starch (HES 130/0.42/6: 1), altered in molar substitution and C2/C6 ratio, is bioequivalent to the former standard HES preparation (130/0.4/9 : 1).

Methods: The two HES solutions were infused (60g as a single dose within 30 minutes) in healthy volunteers using a randomised, crossover design. HES serum concentrations were used for computation of pharmacokinetic parameters; area under the concentration-time curve from infusion start until 24 hours thereafter (AUC₂₄) and maximum serum concentration (C_max) were the primary criteria. Haemodilution, colloid osmotic pressure and plasma viscosity were measured as secondary criteria. Pentastarch (HES 200/0.5/5:1) was investigated in the same volunteers and manner during a subsequent period.

Results: Using non-compartmental analysis, significant differences were found for AUC24 (45.97 ± 8.97 mg • h/mL vs 58.32 ± 9.23 mg • h/mL; HES 130/0.42/ 6: 1 vs HES 130/0.4/9: 1) and total apparent clearance (CL; 1.14 ± 0.4 L/h vs 0.81 ± 0.34 L/h). C_max and elimination half-life (t_1/2) were similar, while the AUC₂₄, t_1/2 and CL of pentastarch were significantly different from those of low substituted HES solutions.

Conclusion: Being equivalent with pentastarch and HES 130/0.4/9: 1 in terms of colloid osmotic and haemodilution effect, HES 130/0.42/6: 1 shows the fastest clearance from the circulation.

The use of trade names is for product identification purposes only and does not imply endorsement.

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Title: Bioequivalence Comparison between Hydroxyethyl Starch 130/0.42/6 : 1 and Hydroxyethyl Starch 130/0.4/9 : 1
Authors: Dr G. Lehmann
G. Marx
H. Förster
Publication date: 01-07-2007
Publisher: Springer International Publishing
Published in: Drugs in R&D / Issue 4/2007
Print ISSN: 1174-5886
Electronic ISSN: 1179-6901
DOI: https://doi.org/10.2165/00126839-200708040-00003

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Bioequivalence Comparison between Hydroxyethyl Starch 130/0.42/6 : 1 and Hydroxyethyl Starch 130/0.4/9 : 1

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

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