ClinicalTrials.Veeva

Menu

Ceftaroline China Pharmacokinetics Study (CeftarolineChi)

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Ceftaroline

Study type

Interventional

Funder types

Industry

Identifiers

NCT01458743
D3720C00005

Details and patient eligibility

About

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.

Full 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 Fosamil as 60-minute Intravenous Infusion Every 12 hours and as 120-minute Intravenous Infusion Every 8 hours.

Enrollment

24 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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 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.

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

Ceftaroline q12h
Experimental group
Description:
Ceftaroline 600mg q12h
Treatment:
Drug: Ceftaroline
Drug: Ceftaroline
Ceftaroline q8h
Experimental group
Description:
ceftaroline 600mg q8h
Treatment:
Drug: Ceftaroline
Drug: Ceftaroline

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems