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 primary objective of the study is to evaluate the effect of food on the pharmacokinetics of SHR4640 tablets in healthy volunteers. The secondary objective of the study is to observe the safety of SHR4640 tablets in healthy subjects.
Subjects were randomly divided into the group A, B. On D1, D8, two groups of subjects were respectively given SHR4640 tablet.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | The subjects in group A did not have breakfast at D1, then were given an SHR4640 tablet. The subjects in group A had a high-fat breakfast on D8. After eating 30min, the subjects in group A were given SHR4640 tablet. |
|
| Group B | Experimental | Group B had high-fat breakfast on D1, no breakfast on D8, and the rest was the same as group A. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR4640 | Drug | Subjects were randomly divided into the group A, B. On D1, D8, two groups of subjects were respectively given SHR4640 tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed concentration, | Day1 to Day11 |
| AUC0-t | Area under the curve from the time of dosing Dosing time to the last measurable (positive) concentration. | Day1 to Day11 |
| AUC0-inf | Area under the curve from time 0 to infinity | Day1 to Day11 |
| Measure | Description | Time Frame |
|---|---|---|
| sUA | concentration of serum urine acid | Day1 to Day11 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng Zhong, Master | Contact | +86 13564101315 | zhongsheng@hrglobe.cn | |
| Yuxiong Gao, PhD | Contact | +86 19821262236 | gaoyuxiong@hrglobe.cn |
| Name | Affiliation | Role |
|---|---|---|
| Beibei Liang, PhD | General Hospital of the Chinese people's Liberation Army | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000720748 | ruzinurad |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided