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The primary objective of the study is to evaluate the effect of itraconazole on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR6390 tablets. The secondary objective of the study is to evaluate the safety of SHR6390 alone and when co-administered with itraconazole. The exploratory objective of the study is to explore the effect of SHR6390 related metabolic enzymes and transporter gene polymorphisms on the pharmacokinetics of SHR6390.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | subjects receiving a single oral dose of SHR6390 tablets, then itraconazole capsules 200 mg/day orally with a single oral dose of SHR6390 tablets co-administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR6390 tablet | Drug | single oral dose of SHR6390 or co-administered with itraconazole. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameter: Cmax of SHR6390 | Peak Plasma Concentration (Cmax) of SHR6390 | through study completion, an average of 32 days |
| Pharmacokinetics parameter: AUC of SHR6390 | Area under the plasma concentration versus time curve (AUC) of SHR6390 | through study completion, an average of 32 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameter: Tmax of SHR6390 | Time of maximum observed concentration (Tmax) of SHR6390 | through study completion, an average of 32 days |
| Pharmacokinetics parameter: T1/2 of SHR6390 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510120 | China |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole capsule |
| Drug |
200 mg itraconazole was administered in the morning. |
|
Half time (T1/2) of SHR6390
| through study completion, an average of 32 days |
| Pharmacokinetics parameter: CL/F of SHR6390 | Total body clearance for extravascular administration (CL/F) of SHR6390 | through study completion, an average of 32 days |
| D010879 |
| Piperazines |