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Pharmacokinetic Interaction Study of Glycopyrrolate and Formoterol in Healthy Volunteers

NCT ID: NCT01398111

Last Updated: 2021-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-08-31

Brief Summary

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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).

Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Treatment R2

Group Type ACTIVE_COMPARATOR

Formoterol

Intervention Type DRUG

formoterol pMDI

Treatment R1

Group Type ACTIVE_COMPARATOR

Glycopyrrolate

Intervention Type DRUG

glycopyrrolate pMDI

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo pMDI

Treatment T

Group Type EXPERIMENTAL

Glycopyrrolate + Formoterol

Intervention Type DRUG

glycopyrrolate pMDI + formoterol pMDI

Interventions

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Glycopyrrolate + Formoterol

glycopyrrolate pMDI + formoterol pMDI

Intervention Type DRUG

Glycopyrrolate

glycopyrrolate pMDI

Intervention Type DRUG

Formoterol

formoterol pMDI

Intervention Type DRUG

Placebo

placebo pMDI

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males and females healthy volunteers aged 18-65 years will be included in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lien Gheyle, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Pharmacology Unit at SGS Life Sciences - Antwerpen (Belgium)

Locations

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Clinical Pharmacology Unit - SGS Life Science Services

Antwerp, Lange Beeldekensstraat 267, Belgium

Site Status

Countries

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Belgium

Related Links

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https://www.chiesi.com/clinic/CSR_Synopsis_CCD-1101-PR-0056.pdf

CSR Synopsis available in the Chiesi Clinical Study Register

Other Identifiers

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2011-001552-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CCD-1101-PR-0056

Identifier Type: -

Identifier Source: org_study_id