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The primary objective of the study is to evaluate the effect of rifampicin on pharmacokinetics of healthy adult subjects after oral administration of HRS-1167 tablets. The secondary objective of the study is to evaluate the safety of HRS-1167 alone and when co-administered with rifampicin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-1167 with rifampicin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-1167 tablets; rifampicin | Drug | HRS-1167 tablets single oral dose of HRS-1167 or co-administered with rifampicin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters of HRS1167: Cmax | Based on pre-dose, 0-72 hours post-dose sampling times | |
| Pharmacokinetics parameters of HRS1167: AUC0-t | Based on pre-dose, 0-72 hours post-dose sampling times | |
| Pharmacokinetics parameters of HRS1167: AUC0-inf | Based on pre-dose, 0-72 hours post-dose sampling times |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters of HRS1167: Tmax | Based on pre-dose, 0-72 hours post-dose sampling times | |
| Pharmacokinetics parameters of HRS1167: t1/2 | Based on pre-dose, 0-72 hours post-dose sampling times |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510260 | 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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Compare the pharmacokinetic effects of Rifampicin on HRS-1167 in healthy subjects.
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| Pharmacokinetics parameters of HRS1167: λz | Based on pre-dose, 0-72 hours post-dose sampling times |
| Pharmacokinetics parameters of HRS1167: AUC_%Extrap | Based on pre-dose, 0-72 hours post-dose sampling times |
| Incidence and severity of adverse events/serious adverse events (base on CTCAE 5.0) | From Day 1 to Day 24 after dose administration |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |