A randomized, double‐blind, comparative study of the pharmacodynamics and pharmacokinetics of GP40141 (romiplostim biosimilar) and reference romiplostim in healthy male volunteers

A randomized, double‐blind, comparative study of the pharmacodynamics and pharmacokinetics of GP40141 (romiplostim biosimilar) and reference romiplostim in healthy male volunteers

Abstract Aims The pharmacodynamic (PD) similarity between GP40141, a proposed romiplostim biosimilar, and reference romiplostim was evaluated. Pharmacokinetics and safety were also assessed. Methods In this phase 1, randomized, double‐blind, single‐dose, crossover comparative study with an adaptive...

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Bibliographic Details
Main Authors: Igor Makarenko, Artem Dorotenko, Sergey Noskov, Veniamin Banko, Valeria Saparova, Alexandr Khokhlov, Evgeniia Zoreeva, Andrey Nedorubov, Bella Zinnatulina, Maria Gefen, Roman Drai
Format: Article
Language:English
Published: Wiley 2023-10-01
Series:Pharmacology Research & Perspectives
Subjects:
biosimilarity
GP40141
pharmacodynamics
pharmacokinetics
romiplostim
Online Access:https://doi.org/10.1002/prp2.1125

Internet

https://doi.org/10.1002/prp2.1125

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