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The purpose of the study is to investigate the SP2086 pharmacokinetic in Renal Insufficiency Patients.
This trial adopt in a parallel, open, single dose study design. The subject was divided into one of five groups according to the degree of renal Insufficiency, which including normal, mild, moderate, severe, and end-stage. All subjects were given SP2086 50mg, and collected the blood samples before and after the medicine taken.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| health volunteers | Active Comparator | this group patients were given SP2086 50mg only one time. |
|
| mild renal insufficiency | Active Comparator | this group patients were given SP2086 50mg only one time. |
|
| moderate renal insufficiency | Active Comparator | this group patients were given SP2086 50mg only one time. |
|
| severe renal insufficiency | Active Comparator | this group patients were given SP2086 50mg only one time. |
|
| end-stage renal insufficiency | Active Comparator | this group patients were given SP2086 50mg only one time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SP2086 | Drug | all subjects were given SP2086 50mg only one time. |
|
| 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 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 a single dose 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 a single dose 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 a single dose 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 |
|---|---|---|
| Jia Miao, P.H.D | West China Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |