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

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2022
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.
Epistemonikos ID: 33e0b0dfa94b31030bfcf4b951dfccaab7291c2a
First added on: May 14, 2024