Study S001152

A Randomized, Open-label, Single-dose, Parallel-controlled Phase I Clinical Trial Comparing the Pharmacokinetic Similarity, Safety, and Immunogenicity of Semaglutide Injection and Ozempic ® Injection in Healthy Subjects.

ClinicalTrials.gov record

Registration

Registration: NCT06634927
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 68
Start: 2024-09-22
Primary completion: 2024-11-14
Lead sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Conditions: Type 2 Diabetes
Interventions: DRUG:Ozempic®; DRUG:HDG1901
Results posted: FALSE

Registered primary outcomes

AUC0-inf [-60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration]
AUC0-t [-60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration]
Cmax [-60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration]

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