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The purpose of the trail is to evaluate the safety, tolerability and pharmacokinetics of a single escalated doses of semaglutide extended-release injectable suspension in healthy adult, human study participants under fasting condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide ER Injectable Suspension, 1 mg | Experimental | Participants receive a single of semaglutide ER injectable suspension at a lower dose 1 mg for safety, tolerability and pharmacokinetics assessements |
|
| Semaglutide ER Injectable Suspension, 4 mg | Experimental | Participants receive a single of semaglutide ER injectable suspension at a medium dose 4 mg for safety, tolerability and pharmacokinetics assessements |
|
| Semaglutide ER Injectable Suspension, 8 mg | Experimental | Participants receive a single of semaglutide ER injectable suspension at a higher dose 8 mg for safety, tolerability and pharmacokinetics assessements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide Extended-release for Injectable Suspension, 1 mg | Drug | Singel-dose; Subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum plasma concentration | From time zero up to the last time point with measurable concentration |
| AUC0-t | Area under the plasma concentration time curve from time zero to the last measurable concentration | From time zero up to the last time point with measurable concentration |
| AUC0-inf | Area under the plasma concentration-time curve from time zero to infinity | From time zero up to the last time point with measurable concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Semaglutide Extended-release for Injectable Suspension, 4 mg | Drug | Singel-dose; Subcutaneous |
|
| Semaglutide Extended-release for Injectable Suspension, 8 mg | Drug | Singel-dose; Subcutaneous |
|
| 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 |
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