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The primary objective of the study is to evaluate the effect of rifampicin 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 rifampicin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | subjects receiving a single oral dose of SHR6390 tablets, then rifampicin capsules 600 mg/day orally with a single oral dose of SHR6390 tablets co-administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR6390 tablet single oral dose of SHR6390 or co-administered with rifampicin | Drug | 600 mg rifampicin was administered in the morning. |
|
| 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 |
|---|---|---|---|---|---|---|
| Zhejiang provincial people's hospital | Hangzhou | Zhejiang | 310014 | China |
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| ID | Term |
|---|---|
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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Half time (T1/2) of SHR6390
| through study completion, an average of 32 days |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |