A study to assess the levels of CAZ-AVI and Metronidazole in the blood when given together and separately

Study identifier:D4280C00012

ClinicalTrials.gov identifier:NCT01534247

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

CAZ-AVI, metronidazole, CAZ-AVI + metronidazole

Sex

All

Actual Enrollment

28

Study type

Interventional

Age

18 Years - 50 Years

Date

Study Start Date: 01 Feb 2012
Primary Completion Date: 01 Jul 2012
Study Completion Date: 01 Jul 2012

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Apr 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Cerexa, Inc.

Inclusion and exclusion criteria