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To evaluate the absorption, metabolism and excretion after a single intravenous infusion of [14C]HRS-8427 in healthy Chinese subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: [14C] HRS-8427 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-8427 | Drug | [14C] HRS-8427 for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| The total radioactive recovery rate and cumulative total radioactive recovery rate at each time interval in excreta (urine and feces) | 0~120hours | |
| The percentage (%AUC) of the potent drug and its metabolites in plasma, urine and feces to the administered dose | 0~120hours | |
| Tmax | 0~48hours | |
| Cmax | 0~48hours | |
| t1/2 | 0~48hours | |
| MRT | 0~48hours | |
| AUC | 0~48hours |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | 0~48hours | |
| Cmax | 0~48hours | |
| MRT | 0~48hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital) | Jinan | Shandong | 250014 | 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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| AUC | 0~48hours |
| t1/2 | 0~48hours |
| Adverse events | 0~120hours |