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Inseung Jeon,1,* Jaeseong Oh,1,* Yu-Kyung Kwon,2 Seo Hyun Yoon,1 Joo-Youn Cho,1 In-Jin Jang,1 Kyung-Sang Yu,1 SeungHwan Lee1 1Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea; 2Department of Clinical Research, Chong Kun Dang, Seoul, Republic of Korea*These authors contributed equally to this workCorrespondence: SeungHwan LeeDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, 103 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of KoreaTel +82 2 2072 2343Fax +82 2 742 9252Email leejh413@snu.ac.krIntroduction: Darbepoetin alfa (NESP® and ARANESP®) has a sustained erythropoietic activity with a longer half-life than conventional recombinant human erythropoietin. CKD-11101 is under clinical development as a biosimilar of darbepoetin alfa. The purpose of this study was to compare the pharmacokinetic (PK), pharmacodynamic (PD), and tolerability profiles of CKD-11101 with those of reference drug in healthy subjects.Methods: This study was performed in two parts for healthy subjects. In each period, CKD-11101 and reference, both at 60 μg, were administered via intravenous (IV) or subcutaneous (SC) route of administration.Results: After both IV or SC dose, the geometric mean ratio (GMR) of CKD-11101 to reference drug and its 90% confidence intervals (CIs) for Cmax, AUC0–last and AUC0–∞ were all within 0.8– 1.25. No statistically significant differences were noted in the maximum baseline adjusted reticulocyte count or the area under the baseline adjusted reticulocyte count-time between the CKD-11101 and reference drug after IV or SC dose (all p-value> 0.05). Both CKD-11101 and reference drug were generally well tolerated.Discussion: After a single IV or SC dose, the CKD-11101 was well tolerated and showed comparable PK and PD characteristics with reference drug.Keywords: pharmacokinetics, pharmacodynamics, biosimilar, darbepoetin alfa

Introduction Darbepoetin alfa (NESP® and ARANESP®) has a sustained erythropoietic activity with a longer half-life than conventional recombinant human erythropoietin. CKD-11101 is under clinical development as a biosimilar of darbepoetin alfa. The purpose of this study was to compare the pharmacokinetic (PK), pharmacodynamic (PD), and tolerability profiles of CKD-11101 with those of reference drug in healthy subjects. Methods This study was performed in two parts for healthy subjects. In each period, CKD-11101 and reference, both at 60 μg, were administered via intravenous (IV) or subcutaneous (SC) route of administration. Results After both IV or SC dose, the geometric mean ratio (GMR) of CKD-11101 to reference drug and its 90% confidence intervals (CIs) for Cmax, AUC0–last and AUC0–∞ were all within 0.8–1.25. No statistically significant differences were noted in the maximum baseline adjusted reticulocyte count or the area under the baseline adjusted reticulocyte count-time between the CKD-11101 and reference drug after IV or SC dose (all p-value>0.05). Both CKD-11101 and reference drug were generally well tolerated. Discussion After a single IV or SC dose, the CKD-11101 was well tolerated and showed comparable PK and PD characteristics with reference drug.

Onions contain antioxidant flavonoids and bioactive sulfur compounds. These substances are more abundant in the peel than in onion flesh. For this reason, whole onions including peels were added to soy milk to produce soy milk with whole onions (SWO), whereas peeled onions were added to soy milk to produce soy milk with peeled onions (SPO). The functional and antioxidant properties of these two kinds of soy milk were then analyzed and compared. Compared to control soy milk (CS) without onion powder, treated samples (to which freeze dried onion powder was added at 1.4, 1.6, 1.8, and 2.0%, respectively) showed significantly increased amounts of quercetin, isoflavone, and total phenol (p