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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14028 injection | Experimental | Subjects receive 14028 injection in the study, 0.75mg, once |
|
| dulaglutide injection (TRULICITY®) | Active Comparator | Subjects receive dulaglutide injection (TRULICITY®) in the study, 0.75mg, once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14028 injection | Biological | 14028 injection, 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 384 hours after administration |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 384 h | 0 hour (pre-dose,within 30mins) to 384 hours after administration |
| Time to reach maximum plasma concentration following drug administration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jie Hou, doctor | Peking University Care Luzhong Hospital | Principal Investigator |
| Hong Wang, bachelor | Peking University Care Luzhong Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PKUCare Luzhong Hospital | Zibo | Shandong | 255400 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | IDF (International Diabetes Federation) Diabetes Atlas, ninth edition, 2019. | ||
| Background | EMA. Trulicity® Risk Management Plan.2021.01.02. | ||
| 26507721 | Background | Geiser JS, Heathman MA, Cui X, Martin J, Loghin C, Chien JY, de la Pena A. Clinical Pharmacokinetics of Dulaglutide in Patients with Type 2 Diabetes: Analyses of Data from Clinical Trials. Clin Pharmacokinet. 2016 May;55(5):625-34. doi: 10.1007/s40262-015-0338-3. | |
| Background | FDA. Guidance for Industry - Clinical pharmacology data to support a demonstration of biosimilarity to a reference product. Dec. 2016. | ||
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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 |
|---|---|
| C555680 | dulaglutide |
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| dulaglutide injection |
| Biological |
dulaglutide injection(TRULICITY®), single dose, s.c. injection |
|
|
Time to maximum concentration |
| 0 hour (pre-dose,within 30mins) to 384 hours after administration |
| Elimination half-life (t1/2) | Elimination half-life | 0 hour (pre-dose,within 30mins) to 384 hours after administration |
| Apparent total body clearance (CL/F) | Apparent total body clearance | 0 hour (pre-dose,within 30mins) to 384 hours after administration |
| Apparent volume of distribution (Vd/F) | Apparent volume of distribution | 0 hour (pre-dose,within 30mins) to 384 hours after administration |
| Elimination constants (λz) | Elimination constants | 0 hour (pre-dose,within 30mins) to 384 hours after administration |
| Background |
| Barrington P, Chien JY, Tibaldi F, Showalter HD, Schneck K, Ellis B. LY2189265, a long-acting glucagon-like peptide-1 analogue, showed a dose-dependent effect on insulin secretion in healthy subjects. Diabetes Obes Metab. 2011 May;13(5):434-8. doi: 10.1111/j.1463-1326.2011.01365.x. Epub 2011 Jan 19. |
| 21251178 | Background | Barrington P, Chien JY, Showalter HD, Schneck K, Cui S, Tibaldi F, Ellis B, Hardy TA. A 5-week study of the pharmacokinetics and pharmacodynamics of LY2189265, a novel, long-acting glucagon-like peptide-1 analogue, in patients with type 2 diabetes. Diabetes Obes Metab. 2011 May;13(5):426-33. doi: 10.1111/j.1463-1326.2011.01364.x. Epub 2011 Jan 19. |
| 28357715 | Background | de la Pena A, Cui X, Geiser J, Loghin C. No Dose Adjustment is Recommended for Digoxin, Warfarin, Atorvastatin or a Combination Oral Contraceptive When Coadministered with Dulaglutide. Clin Pharmacokinet. 2017 Nov;56(11):1415-1427. doi: 10.1007/s40262-017-0531-7. |
| Background | FDA (Food Drug Administration), Clinical Pharmacology Biopharmaceutics Review(s), 2014. |
| Background | EMA (European Medicines Agency), Public assessment report.2014 |
| 38651744 | Derived | Gao X, Di Y, Lv Y, Luan Y, Xiong Y, Xu Y, Li Y, Guo L, Li X, Deng L, Zhuang Y, Hou J. A pharmacokinetic study comparing the biosimilar HEC14028 and Dulaglutide (Trulicity(R)) in healthy Chinese subjects. Clin Transl Sci. 2024 Apr;17(4):e13775. doi: 10.1111/cts.13775. |
| D004700 | Endocrine System Diseases |