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A Study to Investigate the Effect of Administration of Ceftazidime-avibactam (CAZ-AVI) and Ceftaroline Fosamil -Avibactam (CXL) on the Intestinal Flora of Healthy Volunteers

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Research Site
Stockholm, , Sweden
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pharmacokinetics, Open Label, CAZ-AVI, CXL, Effect on Intestinal Flora, Safety
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Provision of signed and dated, written informed consent prior to any study specific
procedures

2. Healthy male and female volunteers aged 18 to 45 years (inclusive) with suitable veins
for cannulation or repeated venepuncture.

Females: Female healthy volunteers are authorised to participate in this study if both
of the following criteria are met:

1. A negative serum pregnancy test BOTH at screening AND at admission to the study
centre.

2. Agrees not to attempt pregnancy while receiving investigational product and for a
period of 7 days after last investigational product administration, and agrees to
the use of acceptable methods of contraception (according to instructions) prior
to, during, and for 7 days after the last investigational product administration.

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. History or presence of gastrointestinal, hepatic, or renal disease or any other
condition known to interfere with the absorption, distribution, metabolism, or
excretion of drugs.

2. Any clinically significant abnormalities in physical examination, ECG, clinical
chemistry, haematology, coagulation, or urinalysis results, as judged by the
investigator.

3. Pregnant or breastfeeding female healthy volunteers.

4. History of any clinically significant disease or disorder which, in the opinion of the
investigator, may either put the healthy volunteer at risk because of participation in
the study, or influence the results or the healthy volunteer's ability to participate
in the study.

5. Known history of Clostridium difficile infection in last 3 months.

NCT01789528
Pfizer
Completed
A Study to Investigate the Effect of Administration of Ceftazidime-avibactam (CAZ-AVI) and Ceftaroline Fosamil -Avibactam (CXL) on the Intestinal Flora of Healthy Volunteers

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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