Ceftaroline China Pharmacokinetics Study (CeftarolineChi)

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.