NCT01789528

A Study to Investigate the Effect of Administration of Ceftazidime-avibactam (CAZ-AVI) and Ceftaroline Fosamil -Avibactam (CXL) on the Intestinal Flora of Healthy Volunteers

A Phase 1, Open-label, Multiple-dose, Single Centre Study to Investigate the Effect of Administration of CAZ-AVI and CXL on the Intestinal Flora of Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the effect of administration of CAZ-AVI and CXL on the intestinal flora of male and female healthy volunteers after multiple administrations over 7 days. An assessment of the effect on intestinal flora is an important aspect to understand for the safe clinical use of the investigational products and is expected by regulatory agencies.

Conditions

• Pharmacokinetics
• Open Label
• CAZ-AVI
• CXL
• Effect on Intestinal Flora
• Safety

Interventions

Type	Name	Description
DRUG	CAZ-AVI	IV infusion
DRUG	CXL	IV infusion

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2013-02-12
• Last updated: 2017-09-05

Locations

1 site across 1 country: Sweden