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Clinical Trial 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.


Clinical Trial Description

The goal of this study, conducted as a double-blind, randomized, cross-over study of comparative pharmacodynamics and pharmacokinetics, is to compare pharmacodynamics, pharmacokinetics, and safety of drugs containing romiplostim - GP40141 and Nplate® in healthy volunteers after a single subcutaneous injection. research objectives is: 1. Evaluate pharmacodynamic and pharmacokinetic parameters of active ingredients of preparations GP40141 and Enplate®. 2. Conduct a comparative analysis of pharmacodynamic and pharmacokinetic parameters of active substances drugs GP40141 and Enplate®. 3. Conduct a comparative analysis of data on adverse events (AE) and evaluate immunogenicity after a single subcutaneous administration of GP40141 versus Enplate®. A conclusion about the biosimilarity of drugs will be made by assessing 90% confidence intervals for the ratios of the geometric mean values of the primary pharmacodynamic parameters. The safety of the compared drugs will be assessed by emergence and development of AE. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05652595
Study type Interventional
Source Geropharm
Contact Igor Mr Makarenko, PhD
Phone +78124935501
Email Igor.Makarenko@geropharm.com
Status Recruiting
Phase Phase 1
Start date June 3, 2022
Completion date September 30, 2024

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