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This is a phase I study to evaluate the effect of Itraconazole on the pharmacokinetics of HRS-8080 in healthy participants and the safety of HRS-8080 administered alone and in combination with Itraconazole in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-8080 Tablets and Itraconazole Capsules Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-8080 Tablet | Drug | HRS-8080 tablet, specified dose on specified days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) of HRS-8080. | From Day 1 to Day 11. | |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast) of HRS-8080. | From Day 1 to Day 11. | |
| Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of HRS-8080. | From Day 1 to Day 11. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum plasma concentration (Tmax) of HRS-8080. | From Day 1 to Day 11. | |
| Terminal elimination half-life (t1/2) of HRS-8080. | From Day 1 to Day 11. | |
| Apparent volume of distribution (Vz/F) of HRS-8080. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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 | Itraconazole capsule, specified dose on specified days. |
|
| From Day 1 to Day 11. |
| Clearance (CL/F) of HRS-8080. | From Day 1 to Day 11. |
| Adverse events (AEs). | From Day 1 to Day 17. |
| Serious adverse events (SAEs). | From Day 1 to Day 17. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D010879 |
| Piperazines |