title: A comparative pharmacokinetic and pharmacodynamic study of FSK0808 versus reference filgrastim after repeated subcutaneous administration in healthy Japanese men.
abstract: FSK0808, a biosimilar of filgrastim, is a recombinant human granulocyte colony-stimulating factor developed by Fuji Pharmaceuticals and Mochida Pharmaceutical Co., Ltd. We conducted a double-blind, randomized, crossover study in healthy Japanese men, comparing the number of CD34-positive cells (CD34(+) cells) after repeated subcutaneous administration of either FSK0808 or the reference filgrastim (Gran(®) ). As primary endpoints, we compared the maximum number of CD34(+) cells (CD34(+)  Cmax ) and the time to reach CD34(+) Cmax (CD34(+) tmax ). As secondary endpoints, we compared the area under the curve for the number of CD34(+) cells over time at the 410 hours time point (CD34(+) AUC0-410 ), the parameters used to calculate the pharmacodynamic index of the absolute neutrophil count, and the pharmacokinetic parameters. Regarding the CD34(+) Cmax and the CD34(+) AUC0-410 values, the 95% confidence interval (CI) of the differences between the mean values for each drug was within the range of log(0.8)-log(1.25). With respect to the differences in the median values between drugs, the ratio against the reference filgrastim median value in the 95% CI was within the range of ± 0.2 for the CD34(+) tmax value. From these results, we considered that these drugs display equivalent pharmacodynamic and pharmacokinetic properties.
authors.affiliation: From the LTA Medical Corporation Kyushu Clinical Pharmacology Research Clinic, 2-13-16, Jigyo Chuo-ku, Fukuoka, 810-0064, Japan.
authors.forename: Kyoko
authors.initials: K
authors.lastname: Matsuguma
authors.affiliation: From the LTA Medical Corporation Kyushu Clinical Pharmacology Research Clinic, 2-13-16, Jigyo Chuo-ku, Fukuoka, 810-0064, Japan.
authors.forename: Shunji
authors.initials: S
authors.lastname: Matsuki
authors.affiliation: From the LTA Medical Corporation Kyushu Clinical Pharmacology Research Clinic, 2-13-16, Jigyo Chuo-ku, Fukuoka, 810-0064, Japan.
authors.forename: Kei
authors.initials: K
authors.lastname: Sakamoto
authors.affiliation: From the LTA Medical Corporation Kyushu Clinical Pharmacology Research Clinic, 2-13-16, Jigyo Chuo-ku, Fukuoka, 810-0064, Japan.
authors.forename: Masanari
authors.initials: M
authors.lastname: Shiramoto
authors.affiliation: From the LTA Medical Corporation Kyushu Clinical Pharmacology Research Clinic, 2-13-16, Jigyo Chuo-ku, Fukuoka, 810-0064, Japan.
authors.forename: Misato
authors.initials: M
authors.lastname: Nakagawa
authors.affiliation: From the LTA Medical Corporation Kyushu Clinical Pharmacology Research Clinic, 2-13-16, Jigyo Chuo-ku, Fukuoka, 810-0064, Japan.
authors.forename: Miyuki
authors.initials: M
authors.lastname: Kimura
authors.affiliation: From the LTA Medical Corporation Kyushu Clinical Pharmacology Research Clinic, 2-13-16, Jigyo Chuo-ku, Fukuoka, 810-0064, Japan.
authors.forename: Shin
authors.initials: S
authors.lastname: Irie
authors.affiliation: Fuji Pharma Co., Ltd., 5-7 Sanban-cho, Chiyoda-ku, Tokyo, 102-0075, Japan.
authors.forename: Daiki
authors.initials: D
authors.lastname: Kaneko
authors.affiliation: Department of Laboratory Medicine, The Jikei University School of Medicine, 4-11-1 Izumihoncho, Komae, Tokyo, 201-8601, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Ohnishi
mesh_terms: D000328:Adult; D018952:Antigens, CD34 / Q000097:blood; D019540:Area Under Curve; D044466:Asian People; D015415:Biomarkers / Q000097:blood; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D000069585:Filgrastim / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D064368:Healthy Volunteers; D006412:Hematopoietic Stem Cells / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D007564:Japan; D008297:Male; D013810:Therapeutic Equivalency; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018952:Antigens, CD34; D015415:Biomarkers; D059451:Biosimilar Pharmaceuticals; C584207:FSK0808; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim