PMID- 24471477
OWN - NLM
STAT- MEDLINE
DCOM- 20160104
LR  - 20221207
IS  - 1520-5762 (Electronic)
IS  - 0363-9045 (Linking)
VI  - 41
IP  - 3
DP  - 2015 Mar
TI  - Pharmacokinetics and pharmacodynamics of FSK0808 and Gran after single 
      intravenous drip administration or single subcutaneous administration: 
      comparative study in healthy Japanese adult male subjects.
PG  - 470-5
LID - 10.3109/03639045.2013.879721 [doi]
AB  - 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(R). We verified the pharmacokinetic/pharmacodynamic equivalence of FSK0808 
      and commercially available Gran(R) by a randomized crossover study of single 
      intravenous dose (200 microg/m(2)) and single subcutaneous dose (400 microg/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.
FAU - Matsuguma, Kyoko
AU  - Matsuguma K
AD  - LTA Medical Corporation Kyushu Clinical Pharmacology Research Clinic , Jigyo 
      Chuo-ku, Fukuoka , Japan .
FAU - Matsuki, Shunji
AU  - Matsuki S
FAU - Eunhee, Chung
AU  - Eunhee C
FAU - Watanabe, Akimasa
AU  - Watanabe A
FAU - Tanaka, Asuka
AU  - Tanaka A
FAU - Sakamoto, Kei
AU  - Sakamoto K
FAU - Takeshita, Hiromi
AU  - Takeshita H
FAU - Hitaka, Akiko
AU  - Hitaka A
FAU - Shigetome, Kyoko
AU  - Shigetome K
FAU - Kimura, Miyuki
AU  - Kimura M
FAU - Miyamoto, Akiko
AU  - Miyamoto A
FAU - Irie, Shin
AU  - Irie S
FAU - Kaneko, Daiki
AU  - Kaneko D
FAU - Ohnishi, Akihiro
AU  - Ohnishi A
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140128
PL  - England
TA  - Drug Dev Ind Pharm
JT  - Drug development and industrial pharmacy
JID - 7802620
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 0 (FSK0808)
RN  - 143011-72-7 (Granulocyte Colony-Stimulating Factor)
SB  - IM
MH  - Adult
MH  - *Asian People
MH  - Biosimilar Pharmaceuticals/*administration & dosage/*pharmacokinetics
MH  - Cross-Over Studies
MH  - Double-Blind Method
MH  - Granulocyte Colony-Stimulating Factor/*administration & dosage/*pharmacokinetics
MH  - Healthy Volunteers
MH  - Humans
MH  - Infusions, Intravenous
MH  - Injections, Subcutaneous
MH  - Male
MH  - Young Adult
OTO - NOTNLM
OT  - Biosimilar
OT  - G-CSF
OT  - clinical trial
OT  - filgrastim
OT  - pharmacodynamics
OT  - pharmacokinetics
EDAT- 2014/01/30 06:00
MHDA- 2016/01/05 06:00
CRDT- 2014/01/30 06:00
PHST- 2014/01/30 06:00 [entrez]
PHST- 2014/01/30 06:00 [pubmed]
PHST- 2016/01/05 06:00 [medline]
AID - 10.3109/03639045.2013.879721 [doi]
PST - ppublish
SO  - Drug Dev Ind Pharm. 2015 Mar;41(3):470-5. doi: 10.3109/03639045.2013.879721. Epub 
      2014 Jan 28.