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Study to Assess the Concentration of Avibactam and Ceftazidime in Epithelial Lining Fluid and Plasma

Last updated on March 14, 2019

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Study Location
Research Site
London, , United Kingdom
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Provision of signed and dated, written informed consent prior to any study specific
procedures

- Healthy male and female subjects with veins suitable for cannulation or repeated
venepuncture; female subjects must be postmenopausal or surgically sterile. Female
subjects must have a negative pregnancy test at screening and on admission to the
unit, must not be lactating and must be of non-child-bearing potential

- Male subjects should be willing to use barrier contraception ie, condoms, from dosing
to 3 months after dosing with the IP

- Have a body mass index (BMI) between 19 and 30 kg/m2

- As judged by the Investigator, all the subjects must be able to understand and be
willing to comply with study procedures, restrictions and requirements

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- History or presence of any clinically significant disease or disorder (including a
history of chronic respiratory disease eg, asthma, chronic obstructive pulmonary
disease [COPD], cystic fibrosis or interstitial lung disease) which, in the opinion of
the Investigator, may either put the subject at risk because of participation in the
study, or influence the results or the subject's ability to participate in the study

- History or presence of gastrointestinal, hepatic or renal disease or any other
condition known to interfere with absorption, distribution, metabolism or excretion of
drugs

- Known allergy to lidocaine/lignocaine, midazolam, alfentanyl or other topical
anaesthetics/sedatives in similar classes to these agents

- Any clinically significant illness, medical/surgical procedure or trauma within 4
weeks of the first administration of IP

- Any clinically significant abnormalities in physical examination, lung function test,
ECG, clinical chemistry, haematology, coagulation screen, or urinalysis results as
judged by the Investigator

NCT01395420
Pfizer
Completed
Study to Assess the Concentration of Avibactam and Ceftazidime in Epithelial Lining Fluid and Plasma

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[email protected]

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Pfizer Clinical Trials Contact Center

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