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A Comparative Pharmacokinetic Study of Recombinant Human Serum Albumin With Plasma‐derived Human Serum Albumin in Patients With Liver Cirrhosis
Author(s) -
Ohnishi Kunihiko,
Kawaguchi Atsuhiro,
Nakajima Shunji,
Mori Hiroyuki,
Ueshima Takahiro
Publication year - 2008
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270007310549
Subject(s) - pharmacokinetics , bioequivalence , cirrhosis , albumin , human serum albumin , medicine , pharmacology , serum albumin , confidence interval , gastroenterology , chemistry , chromatography
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 bioequivalence.