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Medicina is published by MDPI from Volume 54 Issue 1 (2018). Articles in this Issue were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence. Articles are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Lithuanian Medical Association, Lithuanian University of Health Sciences, and Vilnius University.
Open AccessArticle

Comparison of the pharmacokinetic and pharmacodynamic properties of two recombinant granulocyte colony-stimulating factor formulations after single subcutaneous administration to healthy volunteers

1
Institute of Physiology and Pharmacology, Medicial Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania
2
Neuroscience Institute, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania
3
Department of Applied Mathematics, Kaunas University of Technology, Kaunas, Lithuania
4
‘‘Biomapas’’ UAB, Kaunas, Lithuania
*
Author to whom correspondence should be addressed.
Medicina 2014, 50(3), 144-149; https://doi.org/10.1016/j.medici.2014.08.001
Received: 9 November 2012 / Accepted: 23 June 2014 / Published: 13 August 2014
Background and objective: The aim of this randomized, single dose, two-period crossover study with two weeks wash-out period was the demonstration of bioequivalence of two recombinant human granulocyte colony-stimulating factor (rG-CSF) formulations after subcutaneous administration of 300 μg comparing their pharmacokinetic (primary endpoints AUC0–24, AUC0–∞ and Cmax) and pharmacodynamic (primary endpoints ANC AUC0–72, ANC AUC0–∞ and ANCmax) profiles in healthy male subjects.
Materials and methods: A total of 36 (23.0 ± 6.0 years, 76.6 ± 7.2 kg) healthy subjects were recruited. Using a 1:1 randomization ratio, subjects were randomly assigned to one of two possible treatment-sequence groups to receive the single dose of test formulation (Gp-02) and reference product (NeupogenTM) concentrations were measured by enzyme-linked immunosorbent assay (ELISA) up to 24 h and the Absolute Neutrophil Count (ANC) was determined using hematology analyzer Coulter STKSTM (Beckman Coulter) up to 72 h after injection. The geometric mean of primary pharmacokinetic and pharmacodynamic variables were considered bioequivalent if the 90% confidence intervals (CI) would fall in the bioequivalence range of 80%–125%.
Results: AUC0–24 (ratio of means 103.4, 90% CI: 95.6–111.9), AUC0–∞ (103.4, 90% CI: 95.7–111.7), Cmax (99.6, 90% CI: 89.0–111.4), ANC AUC0–72 (100.0, 90% CI: 96.6–103.5), ANC AUC0–∞ (100.8, 90% CI: 96.5–105.3), and ANCmax (100.2, 90% CI: 95.4–105.1) were determined. Single doses of test and reference formulations were well tolerated. The incidence of AEs was equally distributed across treatment groups with the most frequent AEs being headache, fever, and back pain.
Conclusions: The study results demonstrated the bioequivalence of Gp-02, a new formulation of filgrastim, and the reference product NeupogenTM.
Keywords: Human granulocyte colonystimulating factor; Biosimilarity; Pharmacokinetics; Pharmacodynamics; Safety Human granulocyte colonystimulating factor; Biosimilarity; Pharmacokinetics; Pharmacodynamics; Safety
MDPI and ACS Style

Sveikata, A.; Gumbrevičius, G.; Šeštakauskas, K.; Kregždytė, R.; Janulionis, V.; Fokas, V. Comparison of the pharmacokinetic and pharmacodynamic properties of two recombinant granulocyte colony-stimulating factor formulations after single subcutaneous administration to healthy volunteers. Medicina 2014, 50, 144-149.

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