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Pharmacokinetic Interaction and the Safety of Inhaled CHF5259 and CHF6001

NCT03004495 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-12-29

No results posted yet for this study

Summary

To evaluate systemic pharmacokinetics of CHF6001 following concomitant administration of CHF6001 and CHF5259, in comparison with the single components, administered in healthy subjects via a multi-dose reservoir NEXThaler® DPI.

Conditions

Interventions

DRUG

CHF5259 and CHF6001

b.i.d. for 14 days

DRUG

CHF5259 + placebo

b.i.d. for 14 days

DRUG

CHF6001 + placebo

b.i.d. for 14 days

OTHER

Placebo

b.i.d. for 14 days

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Ronnie Beboso, MD · Quintiles, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT03004495 on ClinicalTrials.gov