Study S002192

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

ClinicalTrials.gov record

Registration

Registration: NCT06497049
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 120
Start: 2023-06-30
Primary completion: 2024-05-05
Lead sponsor: Geropharm
Conditions: Pharmacokinetics; Safety Issues; Bioequivalence
Interventions: DRUG:GP40221; DRUG:ozempic
Results posted: FALSE

Registered primary outcomes

AUC 0-t [-60, -30, 0 minutes and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection]
Cmax [-60, -30, 0 minutes and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection]

Linked records (0)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

No records link to this registration yet.