Study identifier:D4280C00023
ClinicalTrials.gov identifier:NCT01789528
EudraCT identifier:N/A
CTIS identifier:N/A
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.
Pharmacokinetics,, open label,
Phase 1
Yes
CAZ-AVI, CXL
All
48
Interventional
18 Years - 45 Years
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Nov 2015 by AstraZeneca
AstraZeneca
-
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.
Location
Location
Stockholm, Sweden
Arms | Assigned Interventions |
---|---|
Experimental: CAZ-AVI or CXL Cohort 1: CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) by intravenous infusion given over 2 hours, every 8 hours Cohort 2: CXL (600 mg ceftaroline fosamil and 600 mg avibactam) | Drug: CAZ-AVI IV infusion Other Name: Cohort 1 |
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