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Evaluation of Possible Effects on the QTc Interval of CHF 4226 pMDI in Healthy Volunteers

NCT00777595 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2009-03-27

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effect of single doses of therapeutic and supratherapeutic doses of inhaled CHF 4226 pMDI on ventricular repolarization in healthy subjects compared with placebo.

Conditions

Interventions

DRUG

CHF 4226 pMDI

Inhaled solution, single therapeutic dose

DRUG

CHF 4226 pMDI

Inhaled solution, single supratherapeutic dose

DRUG

Placebo

Inhaled solution, single dose of placebo

DRUG

Moxifloxacin

Tablet, oral, 400mg, single dose

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Robert I. Cooper, MD · PRACS Institute, Ltd.

  • Steven E. Linberg, PhD · Chiesi Farmaceutici S.p.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00777595 on ClinicalTrials.gov