���康成人における血清培養または無血清培養にて製造された krn5702（エポエチンアルファ）製剤間の薬物動態の比較

Background The previous formulation of epoetin alfa（KRN5702）in Japan was manufacturedby CHO cells cultured with bovine serum. The protein was confirmed safety because ofusing fetal bovine serum derived from countries of non−BSE and highly purification. Toimprove the manufacturing method, we have developed a new formulation of epoetin alfa producedby serum−free culture（KRN5702SF）.Objectives Our aim is to compare the pharmacokinetics of two formulations of epoetin alfain healthy volunteers after single intravenous（IV）or subcutaneous（SC）administration.Methods Two studies were performed to assess the pharmacokinetics of two epoetin alfaformulations administered by IV（3000 IU）or SC（12000 IU）route. Each study was a singlecentre,open−label, randomized, two−treatment, two−period, crossover study where healthysubjects were enrolled. Pharmacokinetic parameters were compared between two formulationsin both dosing routes.Results There are no significant differences in pharmacokinetic parameters between twoformulations in both IV and SC administration.Conclusion The pharmacokinetic profile of KRN5702SF after IV and SC administrationwas similar to that of KRN5702.（Jpn Pharmacol Ther 2009；37：691−8）KEY WORDS KRN5702，Epoetin alfa，Serum−free，Pharmacokinetics