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A Study to Evaluate the Effects of Indacaterol Maleate (QAB149) as a New Formulation in the EPIC Test Fixture

NCT01845623 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-04-20

No results posted yet for this study

Summary

This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of indacaterol maleate (QAB149), administered via the EPIC test fixture. The study aims to determine whether the novel device has a similar clinical profile as the established concept 1 device.

Conditions

Interventions

DRUG

QAB149 75 mg Concept 1

QAB149 delivered via the concept 1 device.

DRUG

QAB149 75 mg Epic Test Fixture

QAB149 delivered via the EPIC test fixture

OTHER

Placebo Concept 1

Placebo administered via the Concept 1 device.

OTHER

Placebo EPIC Test Fixture

Placebo administered via the EPIC Test Fixture.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2013-12-31
Completion
2013-12-31

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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 NCT01845623 on ClinicalTrials.gov