NCT06497049

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

An Open Randomized Study of Comparative Pharmacokinetics and Biosimilarity of GP40221, Solution for Subcutaneous Administration 1.34 mg/ml (GEROPHARM) and Ozempic®, Solution for Subcutaneous Administration 1.34 mg/ml in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Geropharm · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Pharmacokinetics
• Safety Issues
• Bioequivalence

Interventions

Type	Name	Description
DRUG	GP40221	Solution for Subcutaneous Administration 1.34 mg/ml
DRUG	ozempic	Solution for Subcutaneous Administration 1.34 mg/ml

Timeline

• Start date: 2023-06-30
• Primary completion: 2024-05-05
• Completion: 2024-05-05
• First posted: 2024-07-11
• Last updated: 2024-07-11

Locations

1 site across 1 country: Russia