Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to investigate the potential interaction between SP2086 and Valsartan after multiple oral doses treatment in healthy adult volunteers.
This is an open-label (volunteers will know the names of treatments they are assigned) single-center and cross-over study of SP2086 and Valsartan in healthy adult volunteers. All subject were randomized into two groups, and the drugs will be administered according to the AB and BA sequences, all subjects must completed the two stages(A and B). The A sequence was that Valsartan was taken at 160mg qd on Days1-Day12; SP2086 will be administered orally (by mouth) as 200mg on Days 8-Day12.The B sequence was that SP2086 was taken at 200mg qd dose on Days 8-Day12.There were 6 days washout period between the two stages. The whole study needs 31 days.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SP2086 and Valsartan | Active Comparator | All subject were randomized into two groups,and the drugs will be administered according to the AB and BA sequences,all subjects must completed the two stages(A and B).The A sequence was that Valsartan was taken at 160mg qd on Days1-Day12; SP2086 will be administered orally (by mouth) as 200mg on Days 8-Day12.The B sequence was that SP2086 was taken at 200mg qd dose on Days 8-Day12.There were 6 days washout period between the two stages.The whole study needs 31 days.This group patient was given treatment from A stage to B stage. |
|
| Valsartan and SP2086 | Active Comparator | All subject were randomized into two groups,and the drugs will be administered according to the AB and BA sequences,all subjects must completed the two stages(A and B).The A sequence was that Valsartan was taken at 160mg qd on Days1-Day12; SP2086 will be administered orally (by mouth) as 200mg on Days 8-Day12.The B sequence was that SP2086 was taken at 200mg qd dose on Days 8-Day12.There were 6 days washout period between the two stages.The whole study needs 31 days.This group patient was given treatment from B stage to A stage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SP2086 | Drug | The A sequence was that Valsartan was taken at 160mg qd on Days1-Day12; SP2086 will be administered orally (by mouth) as 200mg on Days 8-Day12.The B sequence was that SP2086 was taken at 200mg qd dose on Days 8-Day12 |
| 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 Day 31 |
| 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 Day 31 |
| 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 valsartan | up to Day 31 |
| 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 Day 31 |
| 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 Day 31 |
| 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 valsartan | up to Day 31 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of volunteers with adverse events as a measure of safety and tolerability | up to Day 31 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| XiaoLan Yong, P.H.D | People's Liberation Army General Hospital of Chengdu Military Region | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People's Liberation Army General Hospital of Chengdu Military Region | Chengdu | China |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Valsartan | Drug | The A sequence was that Valsartan was taken at 160mg qd on Days1-Day12; SP2086 will be administered orally (by mouth) as 200mg on Days 8-Day12.The B sequence was that SP2086 was taken at 200mg qd dose on Days 8-Day12 |
|
| D004700 | Endocrine System Diseases |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |