NCT05652595

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

Double-blind, Randomized Comparative Cross-sectional Study of Pharmacodynamics and Pharmacokinetics of Drugs GP40141, Powder for Solution for Subcutaneous Administration, 250 µg (GEROPHARM LLC, Russia) and Enplate®, Powder for Solution for Subcutaneous Administration, 250 µg (Amgen Europe B.V. ., Netherlands) in Healthy Volunteers With a Single Subcutaneous Injection

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Geropharm · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Pharmacodynamics
• Pharmacokinetics
• Bioequivalence

Interventions

Type	Name	Description
DRUG	GP40141	Once, at a dose of 3 mcg/kg, Subcutaneously in the shoulder area
DRUG	Nplate	Once, at a dose of 3 mcg/kg, Subcutaneously in the shoulder area

Timeline

• Start date: 2022-06-03
• Primary completion: 2024-06-30
• Completion: 2024-09-30
• First posted: 2022-12-15
• Last updated: 2022-12-15

Locations

1 site across 1 country: Russia