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Matsuguma K.,LTA Medical Corporation Kyushu Clinical Pharmacology Research Clinic | Matsuki S.,LTA Medical Corporation Kyushu Clinical Pharmacology Research Clinic | Eunhee C.,LTA Medical Corporation Kyushu Clinical Pharmacology Research Clinic | Watanabe A.,LTA Medical Corporation Kyushu Clinical Pharmacology Research Clinic | And 10 more authors.
Drug Development and Industrial Pharmacy | Year: 2015

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 (200μg/m) and single subcutaneous dose (400μg/m) 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. © 2014 Informa Healthcare USA, Inc. All rights reserved: reproduction in whole or part not permitted.


Matsuguma K.,LTA Medical Corporation Kyushu Clinical Pharmacology Research Clinic | Matsuki S.,LTA Medical Corporation Kyushu Clinical Pharmacology Research Clinic | Sakamoto K.,LTA Medical Corporation Kyushu Clinical Pharmacology Research Clinic | Shiramoto M.,LTA Medical Corporation Kyushu Clinical Pharmacology Research Clinic | And 5 more authors.
Clinical Pharmacology in Drug Development | Year: 2015

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 410hours 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. © 2015, The American College of Clinical Pharmacology.

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