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Pharmacokinetic Interaction Study of Glycopyrrolate and Formoterol in Healthy Volunteers

NCT01398111 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2021-10-29

No results posted yet for this study

Summary

This study will be carried out in healthy volunteers with the primary objective to evaluate the pharmacokinetic interaction between Glyco and Formoterol administered using a pressurised metered dose inhaler (pMDI).

Conditions

Interventions

DRUG

Glycopyrrolate + Formoterol

glycopyrrolate pMDI + formoterol pMDI

DRUG

Glycopyrrolate

glycopyrrolate pMDI

DRUG

Formoterol

formoterol pMDI

DRUG

Placebo

placebo pMDI

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Lien Gheyle, MD · Clinical Pharmacology Unit at SGS Life Sciences - Antwerpen (Belgium)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • Belgium

Study Locations

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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 NCT01398111 on ClinicalTrials.gov