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Open Randomized Study of Comparative Pharmacokinetics and Biosimilarity of GP40221 (GEROPHARM LLC, Russia) and Ozempic®.

NCT06497049 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-07-11

No results posted yet for this study

Summary

Study of comparative pharmacokinetics and biosimilarity of drugs containing semaglutide - GP40221 and Ozempic® in healthy volunteers.

Conditions

  • Pharmacokinetics
  • Safety Issues
  • Bioequivalence

Interventions

DRUG

GP40221

Solution for Subcutaneous Administration 1.34 mg/ml

DRUG

ozempic

Solution for Subcutaneous Administration 1.34 mg/ml

Sponsors & Collaborators

  • Geropharm

    lead INDUSTRY

Principal Investigators

  • Sergei Noskov, MD, Pr. · Yaroslavl State Institution of Healthcare "Clinical Hospital No. 3"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2024-05-05
Completion
2024-05-05

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 NCT06497049 on ClinicalTrials.gov