You are here

Ceftaroline China Pharmacokinetics Study

Last updated on December 5, 2018

FOR MORE INFORMATION
Study Location
Beijing, , China
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
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Creatine clearance

- History of any hypersensitivity or allergic reaction to any ?-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.

NCT01458743
Pfizer
Completed
Ceftaroline China Pharmacokinetics Study

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Ceftaroline China Pharmacokinetics Study
A Phase I, Single Center, Open Label, Two Groups Study to Assess the Safety and Pharmacokinetics of Ceftaroline in Healthy Chinese Volunteers Following Single and Multiple Administration of 600 mg Ceftaroline Fosamil as 60-minute Intravenous Infusion Every 12 Hours and as 120-minute Intravenous Infusion Every 8 Hours
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.
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 Fosamil as 60-minute Intravenous Infusion Every 12 hours and as 120-minute Intravenous Infusion Every 8 hours.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: Ceftaroline
    60-minute single intravenous dose of 600 mg of Ceftaroline on Days 1 and 8; 60-minute intravenous dose of 600 mg of Ceftaroline twice per day on Days 3-7.
  • Drug: Ceftaroline
    Single intravenous dose on Days 1 and 9. Intravenous three times per day on Days 2-8.
  • Experimental: Ceftaroline q12h
    Ceftaroline 600mg q12h
    Intervention: Drug: Ceftaroline
  • Experimental: Ceftaroline q8h
    ceftaroline 600mg q8h
    Intervention: Drug: Ceftaroline
Yang L, Sunzel M, Xu P, Edeki T, Wilson D, Li J, Li H. Evaluation of the pharmacokinetics and safety of single and multiple ceftaroline fosamil infusions in healthy Chinese and Western subjects. Int J Clin Pharmacol Ther. 2015 Aug;53(8):681-91. doi: 10.5414/CP202343.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2012
April 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • Creatine clearance <80 mL/min as calculated by the Cockcroft Gault equation
  • History of any hypersensitivity or allergic reaction to any ?-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.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01458743
D3720C00005
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Forest Laboratories
Study Director: David Melnick AstraZeneca Pharmaceuticals-US
Pfizer
September 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021



Call Now