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Clinical Trial Details

Trial ID: L2182
Source ID: NCT06634927
Associated Drug: Ozempic®
Title: Pharmacokinetic Similarity, Safety, and Immunogenicity of Semaglutide Injection and Ozempic ® Injection in Healthy Subjects.
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Ozempic®|DRUG: HDG1901
Outcome Measures: Primary: AUC0-inf, Area Under the Concentration-time curve from time zero to infinite time, -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, Area Under the Concentration-time curve from time zero to the last measurable concentration, -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, Maximum concentration of the active substance in the blood plasma of participants during the observation period, -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration | Secondary: AUC_%Extrap, Extrapolated Part Percentage of 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|Tmax, Time of maximum concentration observed, -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration|t 1/2, Elimination half life, -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration|λz, The Volume of Distribution at Terminal Phase, -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration|CL, Clearance Rate, -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration|Safety and Immunogenicity, Adverse events and positive rate of anti-drug antibodies, AEs will be collected after assigning the ICF. Immunogenicity sample will be collected at -60 minutes and 336、840 hours after administration.
Sponsor/Collaborators: Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 68
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-20
Completion Date: 2025-02-10
Results First Posted:
Last Update Posted: 2024-10-10
Locations: The Second Hospital of Anhui Medical University, Hefei, Anhui, 230601, China
URL: https://clinicaltrials.gov/show/NCT06634927