A study to investigate the effect of administration of ceftazidime-avibactam (CAZ-AVI) and ceftaroline fosamil -avibactam (CXL) on the intestinal flora of healthy volunteers

Study identifier:D4280C00023

ClinicalTrials.gov identifier:NCT01789528

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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.

Medical condition

Pharmacokinetics,, open label,

Phase

Phase 1

Healthy volunteers

Yes

Study drug

CAZ-AVI, CXL

Sex

All

Actual Enrollment

48

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 01 Aug 2013
Primary Completion Date: 01 Mar 2014
Study Completion Date: 01 Mar 2014

Study design

Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Nov 2015 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria