drugset / Trial / 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
Non-randomizedParallel-groupOpen-labelBasic science
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.
Timeline
- Start
- 2013-08
- Primary completion
- 2014-03
- Completion
- 2014-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ceftaroline fosamil | Other / unclassified | 600 mg | Intravenous |
| Subject | Ceftazidime | Small molecule | 2000 mg | Intravenous |
| Subject | avibactam | Small molecule | 500 mg | Intravenous |
| Subject | avibactam | Small molecule | 600 mg | Intravenous |
Indications
No indication recorded.