Study S002077

A Randomized, Open-label, Two-period, Cross-over Trial to Evaluate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Injection Compared With Xultophy® in Healthy Chinese Subjects

ClinicalTrials.gov record

Registration

Registration: NCT06449703
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: UNKNOWN
Enrollment: 44
Start: 2024-05-06
Primary completion: 2024-06-16
Lead sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd
Conditions: Healthy
Interventions: DRUG:insulin degludec/liraglutide; DRUG:Xultophy®
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Maximum observed plasma insulin degludec concentration [0 hours to 120 hours]
Maximum observed plasma liraglutide concentration [0 hours to 72 hours]
Area under the plasma insulin degludec concentration time curve [From 0 to last quantifiable observation after single dose of insulin degludec/liraglutide, assessments from 0 hours to 120 hours]
Area under the plasma liraglutide concentration time curve [From 0 to last quantifiable observation after single dose of insulin degludec/liraglutide, assessments from 0 hours to 72 hours]
Area under the plasma insulin degludec concentration time curve from 0 to infinity after single dose [0 hours to 120 hours]
Area under the plasma liraglutide concentration time curve from 0 to infinity after single dose [0 hours to 72 hours]

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