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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide injection (RD12014)+ Victoza | Experimental | Subjects receive liraglutide injection(RD12014) in the first cycle and Victoza in the second cycle. |
|
| Victoza + Liraglutide injection (RD12014) | Experimental | Subjects receive Victoza in the first cycle and liraglutide injection(RD12014) in the second cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide injection,RD12014 | Drug | single dose, s.c. injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum (peak) plasma drug concentration(Cmax) | Maximum (peak) plasma drug concentration | 0 hour(pre-dose,within 30mins) to 72 hours after administration |
| Area under the plasma concentration-time curve from time zero to time t (AUC0-t) | The area under the plasma concentration curve from 0 to 72 h | 0 hour(pre-dose,within 30mins) to 72 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from time zero to ∞ (AUC0-∞) | The area under the plasma concentration curve from 0 to ∞ | 0 hour(pre-dose,within 30mins) to infinity after administration |
| Time to reach maximum plasma concentration following drug administration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | Shanghai Municipality | 200031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35871497 | Derived | Zhou R, Guo L, Gao X, Wang Y, Xu W, Zou Y, Li W, Zhuang Y, Liu G, Liu Y. A phase I study comparing the pharmacokinetics of the biosimilar (RD12014) with liraglutide (Victoza) in healthy Chinese male subjects. Clin Transl Sci. 2022 Oct;15(10):2458-2467. doi: 10.1111/cts.13374. Epub 2022 Jul 31. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| Liraglutide injection,Victoza | Drug | single dose, s.c. injection |
|
Time to maximum concentration |
| 0 hour(pre-dose,within 30mins) to 72 hours after administration |
| Elimination half-life (t1/2) | Elimination half-life | 0 hour(pre-dose,within 30mins) to 72 hours after administration |
| Apparent total body clearance (CL/F) | Apparent total body clearance | 0 hour(pre-dose,within 30mins) to 72 hours after administration |
| Apparent volume of distribution (Vd/F) | Apparent volume of distribution | 0 hour(pre-dose,within 30mins) to 72 hours after administration |
| Adverse Event, Serious Adverse Event | Monitor the safety indicators of subjects during the trial | Up to day 4 after the second dose. |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |