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This is an open-label, multiple center, parallel-group Study to compare the pharmacokinetics and safety of single-dose benapenem (1.0mg) in subjects with mild or moderate Renal Impairment(RI) and healthy subjects. Subjects were enrolled with defined degrees of RI based on eGFR(estimated Glomerular Filtration Rate) calculated by MDRD (Modification of Diet in Renal Disease)formular as follows: nomal renal function(≥90ml/min/1.73m2 ; N=6); mild RI (60-89mL/min/1.73 m2 ; N=6), moderate RI (30-59 mL/min/1.73m2 ; N=6)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G1 | Experimental | subjects with nomal renal function |
|
| G2 | Experimental | subjects with mild renal impairment |
|
| G3 | Experimental | subjects with moderate renal impairment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| benapenem | Drug | single-dose Benapenem 1.0mg(iv), 60min infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve | Area under the plasma concentration-time curve from time 0 to the time of thelast quantifiable concentration (AUC0-t )of benapenem and the metabolite | predose and 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 hours postdose |
| Area under the plasma concentration-time curve | Area under the plasma concentration-time curve from time 0 to infinity ( AUC0-inf ) of benapenem and the metabolite | predose and 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 hours postdose |
| Maximum observed plasma concentration(Cmax) | Maximum observed plasma concentration(Cmax) of benapenem and the metabolite | predose and 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 hours postdose |
| Observed terminal elimination half-life (T1/2) | Observed terminal elimination half-life (T1/2) of benapenem and its metabolite | predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose |
| Total body clearance (CLt) | Total body clearance (CLt) of benapenem | predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose |
| Apparent volume of distribution (Vz) | Apparent volume of distribution (Vz) based on the terminal phase of benapenem | predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose |
| Cumulative urine exeretion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tongji Hospital | Shanghai | Shanghai Municipality | 200092 | China |
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| ID | Term |
|---|---|
| C000657340 | benapenem |
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| benapenem |
| Drug |
single-dose Benapenem 1.0mg(iv), 60min infusion |
|
| benapenem | Drug | single-dose Benapenem 1.0mg(iv), 60min infusion |
|
Cumulative urine exeretion (Ae0-72h%) of benapenem and its metabolite
| predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose |
| Renal clearance (CLr) | Renal clearance (CLr) of Benapenem and its metabolite | predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose |
| Metabolite-to-parent ratio of AUC0-inf | Metabolite-to-parent ratio of AUC0-inf (MR) | predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose |