Status:
COMPLETED
A Phase I Study to Assess the Safety, Tolerability and PK of Ceftazidime-Avibactam in Healthy Chinese Subjects
Lead Sponsor:
Pfizer
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Investigate the safety and tolerability, as well as PK profile of ceftazidime-avibactam (CAZ -AVI) administered in single and repeated intravenous (IV) infusions in healthy Chinese subjects.This study...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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 β-lactam antibiotics.
- Severe medical or psychiatric condition or laboratory abnormality.
- Blood donation.
- 12 lead ECG abnormal.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01920399
Start Date
October 1 2013
End Date
November 1 2013
Last Update
September 5 2017
Active Locations (1)
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1
Research Site
Shanghai, China