Ceftaroline China Pharmacokinetics Study - CeftarolineChi
Study identifier:D3720C00005
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Single Center, Open Label, Two Groups Study to Assess the Safety and Pharmacokinetics of Ceftaroline in Healthy Chinese Volunteers Following Single and Multiple Administration of 600 mg Ceftaroline Fosamil as 60-minute Intravenous Infusion Every 12 hours and as 120-minute Intravenous Infusion Every 8 hours
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Ceftaroline
Sex
All
Actual Enrollment
24
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Oct 2011
Primary Completion Date: 01 Apr 2012
Study Completion Date: 01 Apr 2012
Study design
Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Jul 2015 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Forest Laboratories, Inc.
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ceftaroline q12h Ceftaroline 600mg q12h | Drug: Ceftaroline 60-minute single intravenous dose of 600 mg of Ceftaroline on Days 1 and 8; 60-minute intravenous dose of 600 mg of Ceftaroline twice per day on Days 3-7. |
| Experimental: Ceftaroline q8h ceftaroline 600mg q8h | Drug: Ceftaroline Single intravenous dose on Days 1 and 9. Intravenous three times per day on Days 2-8. |
Contacts
Investigators
Principal Investigator
David Melnick
AstraZeneca Pharmaceuticals-US
