The Comparability of Etanercept Pharmacokinetics in Healthy Japanese and American Subjects
| Autor: | Shinichi Tsuchiwata, Hanjui Liu, Joan M. Korth-Bradley, Noriaki Yamashita, Shinichi Kawai, Hisayuki Sekino |
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| Rok vydání: | 2006 |
| Předmět: |
Adult
Male medicine.medical_specialty Metabolic Clearance Rate Injections Subcutaneous Recombinant Fusion Proteins Enzyme-Linked Immunosorbent Assay Urine Pharmacology Gastroenterology Receptors Tumor Necrosis Factor White People Etanercept Subcutaneous injection Asian People Japan Pharmacokinetics Internal medicine medicine Humans Single-Blind Method Pharmacology (medical) Dosing Dose-Response Relationship Drug business.industry Healthy subjects Serum samples medicine.disease United States Area Under Curve Immunoglobulin G Rheumatoid arthritis business Half-Life medicine.drug |
| Zdroj: | The Journal of Clinical Pharmacology. 46:418-423 |
| ISSN: | 0091-2700 |
| DOI: | 10.1177/0091270006286435 |
| Popis: | Thirty Japanese (J) and 32 American (A) healthy subjects received single doses of etanercept by subcutaneous injection, in 3 separate trials. Serum samples were collected for 480 hours after dosing. Concentrations were determined using enzyme-linked immunosorbent assay methods. Pharmacokinetic parameters were calculated using both non-compartmental and compartmental methods. Etanercept was slowly absorbed, with mean+/-SD time to maximum serum concentration of 47+/-15 hours (J), and 51+/-20 hours (A). The maximum serum concentration and area under the concentration time curve increased for doses 10 mg, 25 mg, and 50 mg, in a linear relationship. Etanercept was slowly eliminated, with observed mean+/-SD half-life of 80+/-25 hours (J) and 75+/-15 hours (A) and mean+/-SD apparent clearance of 144+/-65 mL/h (J) and 132+/-74 mL/h (A). Very low concentrations of etanercept were observed in the urine samples collected in the Japanese subjects. All adverse reactions observed resolved without issue, and none required discontinuation from the study. |
| Databáze: | OpenAIRE |
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