Status:
COMPLETED
Ceftaroline China Pharmacokinetics Study
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Forest Laboratories
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of ceftaroline in Chinese healthy subjects following single and multiple intravenous doses.
Detailed Description
A Phase I, Single Center and Open Label Study to Assess the Safety and Pharmacokinetics of Ceftaroline in Healthy Chinese Volunteers Following Single and Multiple Administration of 600 mg Ceftaroline ...
Eligibility Criteria
Inclusion
- Provision of informed consent prior to any study specific procedures.
- Are healthy male or female Chinese volunteers aged between 18 and 45 inclusive.
- Have a Body Mass Index (BMI) between (and including) 19 and 24 kg/m2 and weigh at least 50 kg.
- Be willing to communicate with the investigator and comply with all study procedures.
Exclusion
- Creatine clearance \<80 mL/min as calculated by the Cockcroft Gault equation
- History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial.
- Symptoms of any clinically significant illness within 2 weeks of screening.
- Use of any other investigational compound or participation in another clinical trial within 2 months prior to Visit 2.
- Blood donation with 3 months of screening.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01458743
Start Date
October 1 2011
End Date
April 1 2012
Last Update
September 5 2017
Active Locations (1)
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1
Beijing, China