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 Itraconazole on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR2554 tablets.
The secondary objective of the study is to evaluate the safety of single dose of SHR2554 orally in healthy subjects.
SHR2554 50 mg QD on Day 1 and Day 8, Itraconazole 200 mg once daily (QD) from Study Day 4 - 12
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR2554+Itraconazole | Experimental | SHR2554 50 mg QD on Day 1 and Day 8, Itraconazole 200 mg once daily (QD) from Study Day 4 - 12 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR2554 and Itraconazole | Drug | Single dose of oral administration of SHR2554 and Multiple dose of oral of Itraconazole Capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Pharmacokinetics parameter of SHR2554 | Day 1 and Day 11 |
| AUC0-t | Pharmacokinetics parameter of SHR2554 | Day 1 and Day 11 |
| AUC0-∞ | Pharmacokinetics parameter of SHR2554: AUC0-∞ | Day 1 and Day 11 |
Not provided
Not provided
Inclusion Criteria:
Subjects must meet all of the following criteria to enter the study:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital of Central South University | Changsha | Hunan | China |
Not provided
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D010879 |
| Piperazines |