Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002212-20 | EudraCT Number | ||
| U1111-1130-3931 | Other Identifier | WHO |
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
This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) between subcutaneous injections of semaglutide produced by two manufacturing processes.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation A followed by Formulation B | Experimental |
| |
| Formulation B followed by Formulation A | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | For subcutaneous (s.c., under the skin), single dose administration at two separate dosing visits. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma semaglutide concentration curve | 0-4 weeks after a single dose s.c. semaglutide administration | |
| Cmax, the maximum plasma semaglutide concentration | 20-40 hours after a single dose s.c. semaglutide administration |
| Measure | Description | Time Frame |
|---|---|---|
| The area under the plasma semaglutide concentration curve | From time 0 to infinity after a single dose s.c. semaglutide administration | |
| tmax, time to Cmax of semaglutide | 20-40 hours | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berlin | 13353 | Germany |
Not provided
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| t½, terminal elimination half-life of semaglutide |
| 140-200 hours |
| Incidence of adverse events (AEs) | From first dosing to follow-up (5-7 weeks after the second dosing) |
| Hypoglycaemic episodes | From first dosing to follow-up (5-7 weeks after the second dosing) |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591245 | semaglutide |
Not provided
Not provided
Not provided