Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200031, China
NCT Number: NCT05294536
To evaluate the pharmacokinetics similarity between the liraglutide injection (RD12014) produced by Sunshine Lake Pharma Co., Ltd. and liraglutide injection (Victoza®) produced by Novo Nordisk Pharmaceutical Co., Ltd for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and immunogenicity between RD12014 and Victoza ® in healthy subjects.
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Notify Me18 year–45 year
Male
Interventional
Phase 1
Shanghai, Shanghai Municipality, 200031, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
single dose, s.c. injection
single dose, s.c. injection
Time frame: 0 hour(pre-dose,within 30mins) to 72 hours after administration
Maximum (peak) plasma drug concentration
Time frame: 0 hour(pre-dose,within 30mins) to 72 hours after administration
The area under the plasma concentration curve from 0 to 72 h
Time frame: 0 hour(pre-dose,within 30mins) to infinity after administration
The area under the plasma concentration curve from 0 to ∞
Time frame: 0 hour(pre-dose,within 30mins) to 72 hours after administration
Time to maximum concentration
Time frame: 0 hour(pre-dose,within 30mins) to 72 hours after administration
Elimination half-life
Time frame: 0 hour(pre-dose,within 30mins) to 72 hours after administration
Apparent total body clearance
Time frame: 0 hour(pre-dose,within 30mins) to 72 hours after administration
Apparent volume of distribution
Time frame: Up to day 4 after the second dose.
Monitor the safety indicators of subjects during the trial
Sunshine Lake Pharma Co., Ltd.
Industry
A Randomized, Open-label, Two-period, and Double-cross Comparative Study on the Pharmacokinetics of Liraglutide Injection (RD12014) and Victoza® in Healthy Volunteers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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