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The primary objective of the study is to evaluate the relative bioavailability of three different prescription processes of SHR4640 tablets in healthy volunteers. The secondary objective of the study is to observe the safety of SHR4640 tablets in healthy subjects.
Study Type: Interventional Enrollment: Number of Subjects: 24 Type: Anticipated
Allocation : Yes Intervention Model : Single center, randomized, open Intervention Model Description: 3 cycles, 6 sequences Masking: No Masking
Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet. |
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| B | Experimental | Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet. |
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| C | Experimental | Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet. |
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| D | Experimental | Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet. |
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| E | Experimental | Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR4640 | Drug | Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Peak plasma concentration | Day1 to Day25 |
| AUC0-t | Area under the curve from the time of dosing. Dosing time to the last measurable (positive) concentration. | Day1 to Day25 |
| AUC0-inf(if available) | Area under the curve from time 0 to infinity | Day1 to Day25 |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time of maximum observed concentration | Day1 to Day25 |
| t1/2 | Half time | Day1 to Day25 |
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Inclusion Criteria:
Exclusion Criteria:
Subjects will not be allowed to enter this study if they meet any of the following criteria:
1. General situation:
2. Laboratory tests showed the following conditions:
3. There is any history of any of the following or concomitant diseases:
4. Use any of the following drugs or participate in clinical trials:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng Zhong, Master | Contact | 13564101315 | +86 | zhongsheng@hrglobe.cn |
| Yuxiong Gao, PhD | Contact | 19821262236 | +86 | gaoyuxiong@hrglobe.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zourong Ruan, PhD | The Second Affiliated Hospital of Medical College of Zhejiang University | Principal Investigator |
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| ID | Term |
|---|---|
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000720748 | ruzinurad |
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| F | Experimental | Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet. |
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| CL/F | apparent clearance | Day1 to Day25 |
| Vz/F | apparent volume of distribution | Day1 to Day25 |
| PD | concentration of serum urine acid | Day1 to Day25 |