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 this study is to evaluate the effect of food on the PK of a single dose of 52.5 mg Hemay005 in healthy subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemay005 Fast | Experimental |
| |
| Hemay005 Fed | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemay005 | Drug | Hemay005 tablets will be taken orally in dose of 52.5mg at fasted dosing on period one followed by fed dosing on period two. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed plasma concentration | pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8 |
| Tmax | Time of maximum concentration | pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8 |
| AUCt | Area under the plasma concentration-time curve from time zero to the last quantifiable concentration | pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8 |
| AUC∞ | Area under the plasma concentration-time curve from time zero extrapolated to infinity | pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8 |
| t1/2 | Terminal elimination half-life | pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8 |
| CL/F | Apparent total plasma clearance | pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events, serious adverse events | Day 1 up to Day 11±3 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongyun Wang, Doctor | Contact | 86-10-69156576 | wanghy@pumch.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hongyun Wang, Doctor | Peking Union Medical College Hospital | Principal Investigator |
Not provided
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000628605 | Hemay005 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Hemay005 | Drug | Hemay005 tablets will be taken orally in dose of 52.5mg at fed dosing on period one followed by fasted dosing on period two |
|