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The purpose of the study is to investigate the Metabolite identification and material balance of SP2086 in healthy adult volunteers.
All subjects were given SP2086 100mg only one time, and blood sample should be collected before and 96 hours after medicine taken.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SP2086 | Other | SP2086 was taken only one time at 100mg dose in health volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SP2086 | Drug | SP2086 was taken only one time at 100mg dose in health volunteers |
|
| Measure | Description | Time Frame |
|---|---|---|
| The maximum plasma concentration (Cmax) of SP2086 | Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086 | up to 96 hours |
| The maximum plasma concentration (Cmax) of SP2086 acid | Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086 | up to 96 hours |
| The area under the plasma concentration-time curve (AUC) of SP2086 | AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086 | up to 96 hours |
| The area under the plasma concentration-time curve (AUC) of SP2086 acid | AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086 | up to 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The number of volunteers with adverse events as a measure of safety and tolerability | up to 96 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| XingHe Wang, P.H.D | Beijing Shijitan Hospital, Capital Medical University | Principal Investigator |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D004700 | Endocrine System Diseases |