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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
20
FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV treatments as a q8h infusion (90 min) regimen for 10 days
Placebo IV
Spaulding Clinical Research
West Bend, Wisconsin, United States
Safety assessed by number of abnormal clinical laboratory test result
Time frame: every 8 hours
To measure the Maximum Concentration
Time frame: 24 hrs
To measure the Area Under the Curve [AUC]
Time frame: 24 hrs
Safety assessed by number of abnormal physical examinations findings.
Time frame: every 8 hours
Safety assessed by number of abnormal vital signs findings
Time frame: every 8 hours
Safety assessed by number of abnormal 12 Lead ECG findings
Time frame: every 8 hours
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