Study identifier:D4280C00012
ClinicalTrials.gov identifier:NCT01534247
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Open-Label, 3-way Crossover, Pharmacokinetic and Drug-Drug Interaction Study of ceftazidime avibactam (CAZ-AVI) and Metronidazole when Administered Alone and in Combination in Healthy Subjects
Healthy
Phase 1
Yes
CAZ-AVI, metronidazole, CAZ-AVI + metronidazole
All
28
Interventional
18 Years - 50 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Apr 2016 by AstraZeneca
AstraZeneca
Cerexa, Inc.
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: CAZAVI CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) | Drug: CAZ-AVI Infusion |
Active Comparator: Metronidazole Metronidazole (500 mg) | Drug: metronidazole Infusion |
Active Comparator: CAZAVI+metronidazole CAZ-AVI (2000mg ceftazidime/500 mg avibactam) + metronidazole (500 mg) | Drug: CAZ-AVI + metronidazole Infusion |