Double-blind, Randomized Comparative Cross-sectional Study of Pharmacodynamics and Pharmacokinetics of Drugs GP40141

Phase 1 Unknown 56 enrolled Geropharm

RandomizedCrossoverTriple-blindBasic science

Summary

Bioequivalence Study of GP40141 (GEROPHARM) versus Enplate®. The study of comparative pharmacodynamics, pharmacokinetics and safety of drugs containing romiplostim in healthy volunteers after a single subcutaneous injection.

Timeline

Start: 2022-06-03
Primary completion: 2024-06-30
Completion: 2024-09-30

Publications

Makarenko I, Dorotenko A, Noskov S, Banko V, Saparova V, Khokhlov A, Zoreeva E, Nedorubov A, Zinnatulina B, Gefen M, Drai R. A randomized, double-blind, comparative study of the pharmacodynamics and pharmacokinetics of GP40141 (romiplostim biosimilar) and reference romiplostim in healthy male volunteers. Pharmacol Res Perspect. 2023 Oct;11(5):e01125. doi: 10.1002/prp2.1125.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GP40141	Unknown	3 ug/kg	Subcutaneous
Subject	Romiplostim	Peptide	3 ug/kg	Subcutaneous

Indications

No indication recorded.