Pharmacokinetics of oxypolygelatine in healthy volunteers

Eur J Clin Pharmacol. 1999 Mar;55(1):49-51. doi: 10.1007/s002280050591.

Abstract

Objective/methods: The pharmacokinetics of the plasma substitute oxypolygelatine (OPG) were studied in 12 healthy volunteers after single-dose administration of 27 ml x kg(-1) body weight, with a maximum of 2000 ml. OPG was determined in plasma and urine over 48 h after the infusion. Peak plasma OPG concentrations at the end of the infusion were determined to 4.600 (623) microg x ml(-1), the area under the plasma concentration/time curve (AUC(0-infinity)) was calculated to 70.135 (15.861) microg x h x ml(-1).

Results: The model-independently calculated volume of distribution came to 23.1 (4.8) 1 with a clearance total is (Cl(tot)) of 24.6 (6.8) ml x min(-1). The initial half-life according to a three-compartment model came to 0.3 (0.2) h, followed by a distribution half-life of 3.1 (2.6) h and a terminal elimination half-life of 13.4 (2.2) h. Cumulative urinary excretion of OPG was 64% after 48 h.

Conclusion: This low recovery rate may be explained by the distribution of OPG into the extravascular space and subsequent degradation in tissue sites.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I

MeSH terms

  • Contrast Media / pharmacokinetics*
  • Female
  • Gelatin / adverse effects
  • Gelatin / analogs & derivatives*
  • Gelatin / blood
  • Gelatin / pharmacokinetics
  • Gelatin / urine
  • Humans
  • Male
  • Tissue Distribution

Substances

  • Contrast Media
  • Gelatin
  • oxypolygelatine