A comparative pharmacokinetic study of recombinant human serum albumin with plasma-derived human serum albumin in patients with liver cirrhosis

Journal of Clinical Pharmacology
Kunihiko OhnishiTakahiro Ueshima

Abstract

We conducted an open-label, parallel-group study of the high purity, mass-produced recombinant human serum albumin (rHSA), derived from the methylotrophic yeast Pichia pastoris, to compare pharmacokinetics and ensure bioequivalence with plasma-derived human serum albumin (pHSA) in 22 patients with liver cirrhosis. Both rHSA and pHSA groups enrolled 11 patients each, assigned according to predose serum albumin concentrations using the minimization method. Pharmacokinetic and safety profiles for 3-day repeated intravenous infusions at a daily dose of 25 g were evaluated for 8 days. Geometric mean AUC(0-168hr) (g.hr/dL) was 637.12 and 635.93 in the rHSA and pHSA groups, respectively, with a 90% confidence interval (CI) for the difference (92.9%-108.1%) lying within the bioequivalence range. The other major parameter, geometric mean C(max) (g/dL), was 4.16 and 4.19 in the rHSA and pHSA groups, respectively, with a 90% CI for the difference (92.7%-106.4%). The pHSA group presented with 3 adverse events: 1 case of insomnia, and 2 laboratory abnormalities with no serious adverse events. Results from this study show similar pharmacokinetic profiles following intravenous administration of 25g/day of rHSA and pHSA for 3 days, indicating ...Continue Reading

References

Jul 1, 1987·Journal of Bacteriology·C W SaundersM S Guyer
Apr 1, 1997·Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan·W OhtaniT Ohmura
Jul 2, 1999·Protein Engineering·S SugioK Kobayashi
Dec 6, 2001·British Journal of Anaesthesia·P MatejtschukE W Gascoigne
Jun 1, 1953·Proceedings of the Society for Experimental Biology and Medicine·F J DIXONM P DEICHMILLER
Jun 1, 1962·The Journal of Clinical Investigation·W L BEEKENR S STEMLER
Mar 5, 2004·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Bruce A Runyon, UNKNOWN Practice Guidelines Committee, American Association for the Study of Liver Diseases (AASLD)
Dec 17, 2004·Journal of Clinical Pharmacology·Dietrich BosseFritz Schindel
Feb 9, 2006·Biologicals : Journal of the International Association of Biological Standardization·Kaoru Kobayashi

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Citations

May 29, 2009·Pediatric Nephrology : Journal of the International Pediatric Nephrology Association·Kazushi TsurugaHiroshi Tanaka
Dec 24, 2010·Vox Sanguinis·T Burnouf
Nov 22, 2011·Liver International : Official Journal of the International Association for the Study of the Liver·Peter P ReeseMary B Leonard
May 7, 2013·Biochimica Et Biophysica Acta·Zhen ChenDaichang Yang

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