A Comparative Pharmacokinetic Study of Recombinant Human Serum Albumin With Plasma-derived Human Serum Albumin in Patients With Liver Cirrhosis
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 l...
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| Veröffentlicht in: | Journal of clinical pharmacology 2008-02, Vol.48 (2), p.203-208 |
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| creator | Ohnishi, Kunihiko Kawaguchi, Atsuhiro Nakajima, Shunji Mori, Hiroyuki Ueshima, Takahiro |
| description | 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 AUC0–168hr (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 Cmax (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. |
| doi_str_mv | 10.1177/0091270007310549 |
| format | Article |
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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 AUC0–168hr (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 Cmax (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.</description><identifier>ISSN: 0091-2700</identifier><identifier>EISSN: 1552-4604</identifier><identifier>DOI: 10.1177/0091270007310549</identifier><identifier>PMID: 18199895</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Aged ; Area Under Curve ; Bilirubin - blood ; bioequivalence ; Blood Urea Nitrogen ; Comparative analysis ; Creatinine - blood ; Female ; Half-Life ; Humans ; Infusion Pumps ; Injections, Intravenous ; liver cirrhosis ; Liver Cirrhosis - blood ; Liver Cirrhosis - drug therapy ; Liver Cirrhosis - metabolism ; Male ; Middle Aged ; Pharmacokinetics ; Pichia - genetics ; Pichia pastoris ; Properties ; Recombinant human serum albumin ; Recombinant proteins ; Recombinant Proteins - administration & dosage ; Recombinant Proteins - adverse effects ; Recombinant Proteins - pharmacokinetics ; Serum albumin ; Serum Albumin - adverse effects ; Serum Albumin - genetics ; Serum Albumin - pharmacokinetics ; Sex Factors ; Sleep Initiation and Maintenance Disorders - chemically induced ; Therapeutic Equivalency</subject><ispartof>Journal of clinical pharmacology, 2008-02, Vol.48 (2), p.203-208</ispartof><rights>2008 American College of Clinical Pharmacology</rights><rights>2008 SAGE Publications</rights><rights>COPYRIGHT 2008 Sage Publications, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4969-58456647e71be75b4981cf020ee02a3a2a408a9fed3068a4a270304101f0884d3</citedby><cites>FETCH-LOGICAL-c4969-58456647e71be75b4981cf020ee02a3a2a408a9fed3068a4a270304101f0884d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1177%2F0091270007310549$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1177%2F0091270007310549$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27923,27924,45573,45574</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18199895$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ohnishi, Kunihiko</creatorcontrib><creatorcontrib>Kawaguchi, Atsuhiro</creatorcontrib><creatorcontrib>Nakajima, Shunji</creatorcontrib><creatorcontrib>Mori, Hiroyuki</creatorcontrib><creatorcontrib>Ueshima, Takahiro</creatorcontrib><title>A Comparative Pharmacokinetic Study of Recombinant Human Serum Albumin With Plasma-derived Human Serum Albumin in Patients With Liver Cirrhosis</title><title>Journal of clinical pharmacology</title><addtitle>J Clin Pharmacol</addtitle><description>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 AUC0–168hr (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 Cmax (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.</description><subject>Aged</subject><subject>Area Under Curve</subject><subject>Bilirubin - blood</subject><subject>bioequivalence</subject><subject>Blood Urea Nitrogen</subject><subject>Comparative analysis</subject><subject>Creatinine - blood</subject><subject>Female</subject><subject>Half-Life</subject><subject>Humans</subject><subject>Infusion Pumps</subject><subject>Injections, Intravenous</subject><subject>liver cirrhosis</subject><subject>Liver Cirrhosis - blood</subject><subject>Liver Cirrhosis - drug therapy</subject><subject>Liver Cirrhosis - metabolism</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Pharmacokinetics</subject><subject>Pichia - genetics</subject><subject>Pichia pastoris</subject><subject>Properties</subject><subject>Recombinant human serum albumin</subject><subject>Recombinant proteins</subject><subject>Recombinant Proteins - administration & dosage</subject><subject>Recombinant Proteins - adverse effects</subject><subject>Recombinant Proteins - pharmacokinetics</subject><subject>Serum albumin</subject><subject>Serum Albumin - adverse effects</subject><subject>Serum Albumin - genetics</subject><subject>Serum Albumin - pharmacokinetics</subject><subject>Sex Factors</subject><subject>Sleep Initiation and Maintenance Disorders - chemically induced</subject><subject>Therapeutic Equivalency</subject><issn>0091-2700</issn><issn>1552-4604</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkVFv0zAQxyMEYmXwzhPKE28Z59iOnceqYitTNQoD7dFykws1jePOdhj9FPvKuEoFEkJCtuTT3f_39-kuy14TuCBEiHcANSkFAAhKgLP6STYjnJcFq4A9zWbHcnGsn2UvQvgOQCrGyfPsjEhS17Lms-xxni-c3Wuvo_mB-XqrvdWN25kBo2ny2zi2h9x1-WdsnN2YQQ8xX45WD_kt-tHm834zWjPkdyZu83Wvg9VFiz55tf_UpbtOX-EQw8SsktTnC-P91gUTXmbPOt0HfHV6z7Ovl--_LJbF6uPVh8V8VTSsruqCS8arigkUZIOCb1gtSdNBCYhQaqpLzUDqusOWQiU102kKFBgB0oGUrKXn2dvJd-_d_YghKmtCg32vB3RjUCXIihIpkvBiEn7TPSozdC563aTTojWNG7AzKT8ngnJKKgoJgAlovAvBY6f23ljtD4qAOm5N_b21hLw5NTNuLLZ_gNOakoBNggfXR_Rh148P6NUWdR-3yQ-AJb-iBJBpBik6po6-_ISlHg__7UNdL9ZLzqvEFRNnQsSfvzntd6oSVHB1d3OlOBU3dC0_qUv6CzHWv3Y</recordid><startdate>200802</startdate><enddate>200802</enddate><creator>Ohnishi, Kunihiko</creator><creator>Kawaguchi, Atsuhiro</creator><creator>Nakajima, Shunji</creator><creator>Mori, Hiroyuki</creator><creator>Ueshima, Takahiro</creator><general>Blackwell Publishing Ltd</general><general>SAGE Publications</general><general>Sage Publications, Inc</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>M7N</scope></search><sort><creationdate>200802</creationdate><title>A Comparative Pharmacokinetic Study of Recombinant Human Serum Albumin With Plasma-derived Human Serum Albumin in Patients With Liver Cirrhosis</title><author>Ohnishi, Kunihiko ; Kawaguchi, Atsuhiro ; Nakajima, Shunji ; Mori, Hiroyuki ; Ueshima, Takahiro</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4969-58456647e71be75b4981cf020ee02a3a2a408a9fed3068a4a270304101f0884d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Aged</topic><topic>Area Under Curve</topic><topic>Bilirubin - blood</topic><topic>bioequivalence</topic><topic>Blood Urea Nitrogen</topic><topic>Comparative analysis</topic><topic>Creatinine - blood</topic><topic>Female</topic><topic>Half-Life</topic><topic>Humans</topic><topic>Infusion Pumps</topic><topic>Injections, Intravenous</topic><topic>liver cirrhosis</topic><topic>Liver Cirrhosis - blood</topic><topic>Liver Cirrhosis - drug therapy</topic><topic>Liver Cirrhosis - metabolism</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Pharmacokinetics</topic><topic>Pichia - genetics</topic><topic>Pichia pastoris</topic><topic>Properties</topic><topic>Recombinant human serum albumin</topic><topic>Recombinant proteins</topic><topic>Recombinant Proteins - administration & dosage</topic><topic>Recombinant Proteins - adverse effects</topic><topic>Recombinant Proteins - pharmacokinetics</topic><topic>Serum albumin</topic><topic>Serum Albumin - adverse effects</topic><topic>Serum Albumin - genetics</topic><topic>Serum Albumin - pharmacokinetics</topic><topic>Sex Factors</topic><topic>Sleep Initiation and Maintenance Disorders - chemically induced</topic><topic>Therapeutic Equivalency</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ohnishi, Kunihiko</creatorcontrib><creatorcontrib>Kawaguchi, Atsuhiro</creatorcontrib><creatorcontrib>Nakajima, Shunji</creatorcontrib><creatorcontrib>Mori, Hiroyuki</creatorcontrib><creatorcontrib>Ueshima, Takahiro</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><jtitle>Journal of clinical pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ohnishi, Kunihiko</au><au>Kawaguchi, Atsuhiro</au><au>Nakajima, Shunji</au><au>Mori, Hiroyuki</au><au>Ueshima, Takahiro</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Comparative Pharmacokinetic Study of Recombinant Human Serum Albumin With Plasma-derived Human Serum Albumin in Patients With Liver Cirrhosis</atitle><jtitle>Journal of clinical pharmacology</jtitle><addtitle>J Clin Pharmacol</addtitle><date>2008-02</date><risdate>2008</risdate><volume>48</volume><issue>2</issue><spage>203</spage><epage>208</epage><pages>203-208</pages><issn>0091-2700</issn><eissn>1552-4604</eissn><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 AUC0–168hr (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 Cmax (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.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>18199895</pmid><doi>10.1177/0091270007310549</doi><tpages>6</tpages></addata></record> |
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| ispartof | Journal of clinical pharmacology, 2008-02, Vol.48 (2), p.203-208 |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Aged Area Under Curve Bilirubin - blood bioequivalence Blood Urea Nitrogen Comparative analysis Creatinine - blood Female Half-Life Humans Infusion Pumps Injections, Intravenous liver cirrhosis Liver Cirrhosis - blood Liver Cirrhosis - drug therapy Liver Cirrhosis - metabolism Male Middle Aged Pharmacokinetics Pichia - genetics Pichia pastoris Properties Recombinant human serum albumin Recombinant proteins Recombinant Proteins - administration & dosage Recombinant Proteins - adverse effects Recombinant Proteins - pharmacokinetics Serum albumin Serum Albumin - adverse effects Serum Albumin - genetics Serum Albumin - pharmacokinetics Sex Factors Sleep Initiation and Maintenance Disorders - chemically induced Therapeutic Equivalency |
| title | A Comparative Pharmacokinetic Study of Recombinant Human Serum Albumin With Plasma-derived Human Serum Albumin in Patients With Liver Cirrhosis |
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