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

NCT05652595 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-12-15

No results posted yet for this study

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.

Conditions

  • Pharmacodynamics
  • Pharmacokinetics
  • Bioequivalence

Interventions

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

Sponsors & Collaborators

  • Geropharm

    lead INDUSTRY

Principal Investigators

  • Igor Mr Makarenko, PhD · GEROPHAM

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05652595 on ClinicalTrials.gov