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

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

Collaborators

Forest Laboratories, Inc.

Inclusion and exclusion criteria

Location

Beijing, China

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.

"There is no result for the study"

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1375&filename=CSR-D3720C00005.pdf
Download
CSR-D3720C00005.pdf
Download
Revised_CSP_1_Redacted_12.03.14
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

David Melnick

AstraZeneca Pharmaceuticals-US