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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1148-4141 | Other Identifier | WHO | |
| JapicCTI-142572 | Other Identifier | JAPIC |
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This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), pharmacodynamics (the effect of the investigated drug on the body), safety and tolerability of oral semaglutide in healthy male Japanese and Caucasian subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | Once-daily oral administration as tablets. The dose level of oral semaglutide used in the 'Dose escalation period', 'Treatment period 1', 'Treatment period 2' and 'Treatment period 3' will be 5, 10, 20 and 40 mg per day, respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the semaglutide plasma concentration-time curve | During a dosing interval (0-24 hours) at steady state |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed semaglutide plasma concentration | During a dosing interval (0-24 hours) at steady state | |
| Number of treatment emergent adverse events (TEAEs) recorded | From the time of first dosing (Day 1) until completion of the follow-up visit (Days 119-126) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | 130-0004 | Japan |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| placebo | Drug | Once-daily oral administration as tablets. |
|
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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