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.

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.