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| Name | Class |
|---|---|
| Clinartis, LLC | UNKNOWN |
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To evaluate the safety, tolerability and pharmacokinetics (PK) of multiple IV doses of FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) administered every 8 hours (q8h) in healthy adult volunteers for 10 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FEP-TAZ 4 g | Experimental | FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV treatments as a q8h infusion (90 min) regimen for 10 days |
|
| Placebo | Placebo Comparator | placebo IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FEP-TAZ 4 g | Drug | FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV treatments as a q8h infusion (90 min) regimen for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by number of abnormal clinical laboratory test result | every 8 hours | |
| To measure the Maximum Concentration | 24 hrs | |
| To measure the Area Under the Curve [AUC] | 24 hrs | |
| Safety assessed by number of abnormal physical examinations findings. | every 8 hours | |
| Safety assessed by number of abnormal vital signs findings | every 8 hours | |
| Safety assessed by number of abnormal 12 Lead ECG findings | every 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Clinical Research | West Bend | Wisconsin | 53095 | United States |
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Subjects will receive one of the following IV treatments as a q8h infusion (90 min) regimen for 10 days:
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double-blind study
| Placebo | Other | Placebo IV |
|