Pharmacokinetics and pharmacodynamics of FSK0808 and Gran after single intravenous drip administration or single subcutaneous administration: comparative study in healthy Japanese adult male subjects.
FSK0808 is a recombinant human granulocyte colony-stimulating factor developed by Fuji Pharma Co., Ltd and Mochida Pharmaceutical Co., Ltd. as a biosimilar product of Gran®. We verified the pharmacokinetic/pharmacodynamic equivalence of FSK0808 and commercially available Gran® by a randomized crossover study of single intravenous dose (200 µg/m(2)) and single subcutaneous dose (400 µg/m(2)) in healthy Japanese adult male subjects. According to the bioequivalence guidelines, the area under the blood concentration - time curve by 48 hours after administration (AUC0-48) in a single intravenous drip (IVD) study, and AUC0-48 and maximum blood concentration (Cmax) in a single subcutaneous (SC) dose study were used as primary endpoints, and the pharmacodynamic parameters including absolute neutrophil count (ANC) or number of CD34 positive cells (CD34(+) cells) as secondary endpoints. The safety was evaluated based on the characteristics and incidence of adverse reactions. As a result, the 90% confidence interval (CI) of the difference in mean value for AUC0-48 among drugs ranged from log(0.8) to log(1.25), in the IVD study, and those for Cmax and AUC0-48 were within the range of log(0.8)-log(1.25) in the SC study. Those for secondary endpoints were all within the range of log(0.8)-log(1.25). Thus, the pharmacokinetics/pharmacodynamics of both drugs were considered equivalent for all routes of administration, and the profiles of adverse reactions were also very similar.
LTA Medical Corporation Kyushu Clinical Pharmacology Research Clinic , Jigyo Chuo-ku, Fukuoka , Japan .
Kyoko
K
Matsuguma
Shunji
S
Matsuki
Chung
C
Eunhee
Akimasa
A
Watanabe
Asuka
A
Tanaka
Kei
K
Sakamoto
Hiromi
H
Takeshita
Akiko
A
Hitaka
Kyoko
K
Shigetome
Miyuki
M
Kimura
Akiko
A
Miyamoto
Shin
S
Irie
Daiki
D
Kaneko
Akihiro
A
Ohnishi
D000328:Adult; D044466:Asian People; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D064368:Healthy Volunteers; D006801:Humans; D007262:Infusions, Intravenous; D007279:Injections, Subcutaneous; D008297:Male; D055815:Young Adult
D059451:Biosimilar Pharmaceuticals; C584207:FSK0808; D016179:Granulocyte Colony-Stimulating Factor
Biosimilar; G-CSF; clinical trial; filgrastim; pharmacodynamics; pharmacokinetics