Completed
PHASE1
INTERVENTIONAL
NCT06497049
Open Randomized Study of Comparative Pharmacokinetics and Biosimilarity of GP40221 (GEROPHARM LLC, Russia) and OzempicĀ®.
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
Study of comparative pharmacokinetics and biosimilarity of drugs containing semaglutide - GP40221 and OzempicĀ® in healthy volunteers.
Interventions
Name:
GP40221
Type:
DRUG
Description:
Solution for Subcutaneous Administration 1.34 mg/ml
Name:
ozempic
Type:
DRUG
Description:
Solution for Subcutaneous Administration 1.34 mg/ml
Primary Outcomes
Measure:
AUC 0-t
TimeFrame:
-60, -30, 0 minutes and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
Description:
Total area under the "concentration of an active substance - time" curve in the time interval from 0 (the moment of drug administration) to the collection of the last blood sample with a determined concentration of the active substance at time point t
Measure:
Cmax
TimeFrame:
-60, -30, 0 minutes and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
Description:
Maximum concentration of the active substance in the blood plasma of volunteers during the observation period
Trial Information
NCT ID
NCT06497049
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
Geropharm
Last Updated
December 15, 2025