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The Comparability of Etanercept Pharmacokinetics in Healthy Japanese and American Subjects
Author(s) -
Kawai Shinichi,
Sekino Hisayuki,
Yamashita Noriaki,
Tsuchiwata Shinichi,
Liu Hanjui,
KorthBradley Joan M.
Publication year - 2006
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 - 10.1177/0091270006286435
Subject(s) - etanercept , pharmacokinetics , medicine , urine , dosing , discontinuation , volunteer , adverse effect , serum concentration , half life , pharmacology , rheumatoid arthritis , agronomy , biology
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 noncompartmental 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.