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A Study to Assess the Levels of Two Antibiotics in the Blood When Given Together and Separately

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 aged 18 to 50 years 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 admi

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

- 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 of any clinically significant disease or disorder 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

- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as
judged by the Investigator or history of hypersensitivity to drugs with a similar
chemical structure or class to avibactam, ceftazidime, and/or excipients

- Any clinically significant illness, medical/surgical procedure or trauma within 4
weeks of the first administration of IP Prolonged QTcF (>450 ms) or shortened QTcF
(

NCT01430910
Pfizer
Completed
A Study to Assess the Levels of Two Antibiotics in the Blood When Given Together and Separately

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