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

• Main Authors: Igor Makarenko (Author), Artem Dorotenko (Author), Sergey Noskov (Author), Veniamin Banko (Author), Valeria Saparova (Author), Alexandr Khokhlov (Author), Evgeniia Zoreeva (Author), Andrey Nedorubov (Author), Bella Zinnatulina (Author), Maria Gefen (Author), Roman Drai (Author)
• Format: Book
• Published: Wiley, 2023-10-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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...