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The purpose of the study is to investigate the potential PK interaction between SP2086 and Valsartan after multiple oral doses treatment in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SP2086 and Valsartan | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SP2086 | Drug | SP2086 will be administered orally (by mouth) as 100mg on Days 4, 5, 6, 7, and 8 and Valsartan will be administered orally as two 80mg tablets on Days 1 and 8. Both SP2086 and Valsartan tablets will be taken with 8 ounces (240 mL) of water. |
| 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 Valsartan | up to Day 9 |
| 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 Valsartan | up to Day 9 |
| The maximum plasma concentration (Cmax) of Valsartan | Cmax (a measure of the body's exposure to Valsartan) will be compared. before and after administration of multiple doses of SP2086 | up to Day 9 |
| 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 a single dose of Valsartan. | up to Day 9 |
| 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 a single dose of Valsartan. | up to Day 9 |
| The area under the plasma concentration-time curve (AUC) of Valsartan | AUC (a measure of the body's exposure to Valsartan) will be compared before and after administration of multiple doses of SP2086 | up to Day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of volunteers with adverse events as a measure of safety and tolerability | up to Day 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People's Liberation Army General Hospital of Chengdu Military Region | Recruiting | Chengdu | Sichuan | 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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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Valsartan | Drug | SP2086 will be administered orally (by mouth) as100mg on Days 4, 5, 6, 7, and 8 and Valsartan will be administered orally as two 80mg tablets on Days 1 and 8. Both SP2086 and Valsartan tablets will be taken with 8 ounces (240 mL) of water. |
|
| D004700 | Endocrine System Diseases |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |