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A Phase I Study to Assess the Safety, Tolerability and PK of Ceftazidime-Avibactam in Healthy Chinese Subjects

Last updated on March 14, 2019

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Study Location
Research Site
Shanghai, , China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
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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- Provision of signed and dated, written informed consent prior to any study-specific
procedures.

- Healthy male and female (of non-child bearing potential) Chinese subjects, with
suitable veins for cannulation or repeated venipuncture

- BMI 19 to 24 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Any clinical condition requiring the regular use of any medication.

- Consumption of alcohol, drug, tobacco (cigarettes).

- Sensitive to any food, or any serious reaction to carbapenem, cephalosporin, or other
?-lactam antibiotics.

- Severe medical or psychiatric condition or laboratory abnormality.

- Blood donation.

- 12 lead ECG abnormal.

NCT01920399
Pfizer
Completed
A Phase I Study to Assess the Safety, Tolerability and PK of Ceftazidime-Avibactam in Healthy Chinese Subjects

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Pfizer Clinical Trials Contact Center

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