PKUCare Luzhong Hospital
Zibo, Shandong, 255400, China
NCT Number: NCT05459285
To evaluate the pharmacokinetics similarity between the 14028 injection produced by Sunshine Lake Pharma Co., Ltd. and dulaglutide injection (TRULICITY®) produced by Eli Lilly and Company for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and immunogenicity between 14028 Injection and TRULICITY® in Healthy Subjects
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Notify Me18 year–45 year
Male
Interventional
Phase 1
Zibo, Shandong, 255400, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
14028 injection, single dose, s.c. injection
dulaglutide injection(TRULICITY®), single dose, s.c. injection
Other names: TRULICITY®
Time frame: 0 hour (pre-dose,within 30mins) to 384 hours after administration
Maximum (peak) plasma drug concentration
Time frame: 0 hour (pre-dose, within 30mins) to infinity
The area under the plasma concentration curve from 0 to ∞
Time frame: 0 hour (pre-dose,within 30mins) to 384 hours after administration
The area under the plasma concentration curve from 0 to 384 h
Time frame: 0 hour (pre-dose,within 30mins) to 384 hours after administration
Time to maximum concentration
Time frame: 0 hour (pre-dose,within 30mins) to 384 hours after administration
Elimination half-life
Time frame: 0 hour (pre-dose,within 30mins) to 384 hours after administration
Apparent total body clearance
Time frame: 0 hour (pre-dose,within 30mins) to 384 hours after administration
Apparent volume of distribution
Time frame: 0 hour (pre-dose,within 30mins) to 384 hours after administration
Elimination constants
Sunshine Lake Pharma Co., Ltd.
Industry
Pharmacokinetics, Safety and Immunogenicity of 14028 Injection Versus Dulaglutide Injection in Healthy Subjects: a Phase I ,Single-center, Randomized, Open-label, Single-dose, Parallel-controlled Clinical Study
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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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