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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1289-1040 | Other Identifier | World Health Organization (WHO) |
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In this study, a known medicine called 'semaglutide' will be tested in two different tablet versions. The two tablets differ in the way these have been manufactured. The aim of the study is to investigate the amount of active ingredient in the blood after dosing the different tablet versions. Participants will receive one tablet version for 10 days (first treatment period) and the other version for 10 days (second treatment period). The treatment arm participants will be assigned to is decided by chance. The study will last for about 23 weeks for each participant. The study will enroll healthy male participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: Semaglutide J then Semaglutide K | Experimental | Oral semaglutide J will be administered in treatment period 1 followed by semaglutide K in treatment period 2. |
|
| Sequence 2: Semagultide K then Semaglutide J | Experimental | Oral semaglutide K will be administered in treatment period 1 followed by semaglutide J in treatment period 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted AUC0-24h,sema; adjusted area under the semaglutide plasma concentration-time curve | Measured in hour*nanomoles per liter (h*nmol/L). | From 0 to 24 hours after dosing on day 80 and 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Cmax,0-24h,sema; adjusted maximum observed semaglutide plasma concentration | Measured in nanomoles per liter (nmol/L). | From 0 to 24 hours after dosing on day 80 and 90 |
| Adjusted tmax,0-24h,sema; time to adjusted maximum observed semaglutide plasma concentration |
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Key inclusion criteria:
Key exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences Clinical Company, Inc | Montreal | Quebec | H3P 3P1 | Canada |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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Measured in hours. |
| From 0 to 24 hours after dosing on day 80 and 90 |
| t½,sema; the terminal half-life of semaglutide | Measured in hours. | From 0 to 840 hours after dosing on day 90 |