Study identifier:D4280C00020
ClinicalTrials.gov identifier:NCT01920399
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Ceftazidime-Avibactam Administered as Single and Repeated Intravenous Doses in Healthy Chinese Subjects
Healthy Volunteers
Phase 1
Yes
CAZ-AVI, 0.9% Normal Saline
All
42
Interventional
18 Years - 45 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Other
Verified 01 Feb 2016 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Placebo Comparator: Placebo IV infusions of 0.9% normal saline | Drug: 0.9% Normal Saline A single 120 minute IV infusion on Day 1, followed by three times daily (every 8 hours, q8h) as 120 minute IV infusions for 7 days (Day 2 to Day 8), and one single 120 minute IV infusion on Day 9. |
Experimental: CAZ-AVI IV infusion of AVI 500 mg + CAZ 2000 mg. | Drug: CAZ-AVI A single 120 minute IV infusion on Day 1, followed by three times daily (every 8 hours, q8h) as 120 minute IV infusions for 7 days (Day 2 to Day 8), and one single 120 minute IV infusion on Day 9. |