ABOUT THIS STUDY
Subjects must meet one of the following renal function categories:
- Normal renal function (CLcr >80 mL/min).
- Mild renal impairment (CLcr >50 and <80 mL/min).
- Moderate renal impairment (CLcr >30 and <50 mL/min).
- Severe renal impairment (CLcr <30 mL/min).
Women who are pregnant or nursing or women who are of childbearing potential. History of
clinically significant allergies, including seasonal allergies, and especially drug
hypersensitivity including known allergies to components of the study drug formulation,
penicillin, carbapenems and/or cephalosporin antibiotics (eg, amoxicillin,
amoxicillin/clavulanate, ampicillin, cefadroxil, cephalexin, cefaclor and cefixime).
Subjects should not have evidence of a history of the following:
- normal renal function: clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological or
- renal impairment: any clinically significant (hepatic, cardiac or pulmonary or
subjects with acute nephritic syndrome) diseases (except diabetes). Stable co-morbid
disease where it is unlikely that the disease and medication will alter the outcome of
the study will be allowed.
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