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The primary objective of the study is to evaluate the effect of Rifampin 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 oral administration of SHR2554 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Single-dose oral administration of SHR2554 and multiple-dose oral administration of Rifampin Capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR2554 and Rifampin | Drug | Single-dose oral administration of SHR2554 and multiple-dose oral administration of Rifampin Capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameter: Cmax of SHR2554 | Peak Plasma Concentration (Cmax) of SHR2554 | from Day 1 to Day 13 |
| Pharmacokinetics parameter: AUC of SHR2554 | Area under the plasma concentration versus time curve (AUC) of SHR2554 | from Day 1 to Day 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Other pharmacokinetics parameter: Tmax of SHR2554 | Time to maximum plasma concentration (Tmax) of SHR2554 | from Day 1 to Day 13 |
| Other pharmacokinetics parameter: T1/2 of SHR2554 | Half-life of elimination (T1/2) of SHR2554 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | Shanghai | 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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| from Day 1 to Day 13 |
| The incidence and severity of adverse events/serious adverse events | Based on NCI-CTC AE 5.0 | from Day 1 to Day 13 |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |