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The purpose of the study is to investigate the potential interaction between SP2086 and Simvastatin after the 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 Simvastatin in healthy adult volunteers. All subject were randomized into two groups, and the drugs will be administered according to the AB and BA sequences. The A sequence was that SP2086 was taken at 40mg qd on Day1-Day 10; Simvastatin will be administered orally (by mouth) as 200mg on Day 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd on Day6-Day10. There were 5 days washout period between A and B. The total time of this trial was 27 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SP2086 and Simvastatin | 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 SP2086 was taken at 200mg qd on Days1-Day10; Simvastatin will be administered orally (by mouth) as 40mg on Days 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd dose on Days 6-Day10.There were 5 days washout period between the two stages.The whole study needs 27 days.This group patient was given treatment from A stage to B stage. |
|
| Simvastatin 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 SP2086 was taken at 200mg qd on Days1-Day10; Simvastatin will be administered orally (by mouth) as 40mg on Days 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd dose on Days 6-Day10.There were 5 days washout period between the two stages.The whole study needs 27 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 SP2086 was taken at 200mg qd on Days1-Day10; Simvastatin will be administered orally (by mouth) as 40mg on Days 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd dose on Days 6-Day10. |
| 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 27 |
| 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 27 |
| The maximum plasma concentration (Cmax) of Simvastatin | Cmax (a measure of the body's exposure to Simvastatin) will be compared before and after administration of multiple doses of Simvastatin | up to Day 27 |
| 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 27 |
| 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 27 |
| The area under the plasma concentration-time curve (AUC) of Simvastatin | AUC (a measure of the body's exposure to Simvastatin) will be compared before and after administration of multiple doses of Simvastatin | up to Day 27 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of volunteers with adverse events as a measure of safety and tolerability | up to Day 27 |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
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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 |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Simvastatin | Drug | The A sequence was that SP2086 was taken at 200mg qd on Days1-Day10; Simvastatin will be administered orally (by mouth) as 40mg on Days 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd dose on Days 6-Day10. |
|
| D004700 | Endocrine System Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |