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A Study To Investigate The Pharmacokinetics, Safety And Tolerability Of An Intravenous And Oral Form Of A Compound In Subjects With Varying Degrees Of Renal Impairment And Normal Renal Function

Last updated on February 17, 2019

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Study Location
Centurion Clinical Research
Indianapolis, Indiana, 46260 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumonia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Subjects must meet one of the following renal function categories:

- Normal renal function (CLcr >80 mL/min).

- Mild renal impairment (CLcr >50 and

- Moderate renal impairment (CLcr >30 and

- Severe renal impairment (CLcr

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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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
allergic disease.

- 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.

NCT00759564
Pfizer
Completed
A Study To Investigate The Pharmacokinetics, Safety And Tolerability Of An Intravenous And Oral Form Of A Compound In Subjects With Varying Degrees Of Renal Impairment And Normal Renal Function

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