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This study is a single-center, open-label, sequential drug interaction study
The primary objectives are:
To evaluate the pharmacokinetic effects of HRS-8427 injection on the liver drug enzymes CYP2B6 substrate bupropion and CYP3A4 substrate midazolam in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-8427 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-8427 | Drug | HRS-8427 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Bupropion, hydroxybupropion and midazolam, hydroxymidazolam. Observed maximum plasma concentration. Blood samples will be collected. | 15 Days |
| AUC0-t | Bupropion, hydroxybupropion and midazolam, hydroxymidazolam. Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. Blood samples will be collected. | 15 Days |
| AUC0-∞ | Bupropion, hydroxybupropion and midazolam, hydroxymidazolam. Area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected. | 15 Days |
| Tmax | Bupropion, hydroxybupropion and midazolam, hydroxymidazolam. Observed time to reach Cmax. Blood samples will be collected. | 15 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital Central South University | Changsha | Hunan | 410008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41773934 | Derived | Yin T, Qu B, Zhang Q, Xu S, Wu Y, Jiang H, Huang Y, Hu W. Pharmacokinetics, safety, and tolerability of HRS-8427, a novel anti-carbapenem-resistant cephalosporin, in healthy subjects. Antimicrob Agents Chemother. 2026 Apr;70(4):e0069425. doi: 10.1128/aac.00694-25. Epub 2026 Mar 3. |
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