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SP2086 is a novel inhibitor of Dipeptide base peptidase 4, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this single-dose and multiple-dose study the investigators evaluated the safety, tolerability and Pharmacokinetics profiles of SP2086 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SP2086 50mg | Experimental | there were 3 groups in the study: 50mg ,100mg and 200mg ,each group including 10 healthy volunteers.All subjects were administrated the medicine at Day 1 and Day 5 to Day 9.During the test,collecting the blood samples were needed before and after taking medicine. |
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| SP2086 100mg | Experimental | there were 3 groups in the study: 50mg ,100mg and 200mg ,each group including 10 healthy volunteers.All subjects were administrated the medicine at Day 1 and Day 5 to Day 9.During the test,collecting the blood samples were needed before and after taking medicine. |
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| SP2086 200mg | Experimental | there were 3 groups in the study: 50mg ,100mg and 200mg ,each group including 10 healthy volunteers.All subjects were administrated the medicine at Day 1 and Day 5 to Day 9.During the test,collecting the blood samples were needed before and after taking medicine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SP2086 | Drug | The study has 3 doses groups and the 30 subjects were administrated SP2086 50mg,100mg,200mg respectively. |
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| 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 a single dose of SP2086. | up to Day 13 |
| The steady-state plasma concentration (Css) of SP2086 | Css (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086 | up to Day 13 |
| 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 a single dose of SP2086. | up to Day 13 |
| The steady-state plasma concentration (Css) of SP2086 acid | Css (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086 | up to Day 13 |
| The maximum urine concentration (Cmax) of SP2086 | Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086 | up to Day 13 |
| The steady-state urine concentration (Css) of SP2086 | Css (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086 | up to Day 13 |
| The maximum urine concentration (Cmax) of SP2086 acid |
| Measure | Description | Time Frame |
|---|---|---|
| The number of volunteers with adverse events as a measure of safety and tolerability | up to Day 13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanhua Ding, docter | Contact | 0431-88782168 | dingyanhua2003@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Hosital of Jilin University | Changchun | Jilin | China |
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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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Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086
| up to Day 13 |
| The steady-state urine concentration (Css) of SP2086 acid | Css (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086 | up to Day 13 |
| Cumulative excretion of SP2086 | up to Day 13 |
| D004700 | Endocrine System Diseases |