A Comparative Pharmacokinetic Study of Recombinant Human Serum Albumin With Plasma-derived Human Serum Albumin in Patients With Liver Cirrhosis.

A Comparative Pharmacokinetic Study of Recombinant Human Serum Albumin With Plasma-derived Human Serum Albumin in Patients With Liver Cirrhosis. Research Abstract Details 

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A Comparative Pharmacokinetic Study of Recombinant Human Serum Albumin With Plasma-derived Human Serum Albumin in Patients With Liver Cirrhosis. Abstract Text:

Kunihiko Ohnishi,Atsuhiro Kawaguchi,Shunji Nakajima,Hiroyuki Mori,Takahiro Ueshima,

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.

A Comparative Pharmacokinetic Study of Recombinant Human Serum Albumin With Plasma-derived Human Serum Albumin in Patients With Liver Cirrhosis. Publishing Authors By Initials

K Ohnishi,A Kawaguchi,S Nakajima,H Mori,T Ueshima,

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A Comparative Pharmacokinetic Study of Recombinant Human Serum Albumin With Plasma-derived Human Serum Albumin in Patients With Liver Cirrhosis. Journal Published:

PUBLICATION TYPE: Journal Article

Journal: Journal of clinical pharmacology

VOLUME: 48

Page Numbers: 203-8

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ISSN: 0091-2700

DAY: 17

MONTH: Feb

YEAR: 2008

A Comparative Pharmacokinetic Study of Recombinant Human Serum Albumin With Plasma-derived Human Serum Albumin in Patients With Liver Cirrhosis. Information

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LANGUAGE: eng

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AFFILIATION: Mitsubishi Tanabe Pharma Corporation, 2-2-6 Nihonbashi-Honcho, Chuo-ku, Tokyo 103-8405, Japan; e-mail: Kawaguchi.Atsuhiro@mf.mt-pharma.co.jp.

Country: United States

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MEDLINETA: J Clin Pharmacol

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