Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the single-dose subcutaneous injection of insulin degludec injection (Tresiba®) listed by Novo Nordisk in China as a reference drug, the insulin degludec injection provided by Dongguan Dongyang Sunshine Biopharmaceutical R&D Co., Ltd. (RD15003) pharmacokinetics and pharmacodynamic characteristics in healthy subjects, and then to evaluate the bioequivalence of test drugs and control drugs.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TR sequence | Experimental | Experimental:Insulin degludec injection (RD15003)+Tresiba Subjects receive Insulin degludec injection(RD15003) in the first cycle and Tresiba in the second cycle. |
|
| RT sequence | Experimental | Experimental:Tresiba+Insulin degludec injection (RD15003) Subjects receive Insulin Tresiba in the first cycle and degludec injection(RD15003) in the second cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin degludec injection, RD15003 | Biological | single dose, s.c. injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from time zero to 24 hours | AUC0-24h | 24 hours after injection |
| Area under the glucose infusion rate curve from administration to end of clamp from time zero to 24 hours | GIR-AUC0-24h | 24 hours after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from time zero to 12 hours | AUC0-12h | 12 hours after injection |
| Area under the glucose infusion rate curve from administration to end of clamp from time zero to 12 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Insulin degludec, Tresiba | Biological | single dose, s.c. injection |
|
AUCGIR0-12h
| 12 hours after injection |
| Safety evaluation | Incidence of adverse events | Up to 24 weeks |
| Area under the plasma concentration-time curve from time 12 hours to 24 hours | AUC12-24h | 12-24 hours after injection |
| Area under the plasma concentration-time curve from time zero to t | AUC0-t | 120 hours after injection |
| Area under the glucose infusion rate curve from administration to end of clamp from time 12 hours to 24 hours | AUCGIR, 12-24h | 12-24 hours after injection |
| Maximum glucose infusion rate | GIRmax | 24 hours after injection |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C571886 | insulin degludec |
Not provided
Not provided
Not provided