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Study to Determine the Amount of Glycopyrrolate Absorbed in the Lungs After Taking the Medicine With a eFlow Nebulizer and Seebri® Breezhaler® With and Without Activated Charcoal in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD).

NCT02512302 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-10-25

Study results available
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Summary

The purpose of this research study is to determine the amount of medicine absorbed in the lungs following dosing via eFlow nebulizer and Seebri® Breezhaler® with and without activated charcoal in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).

Conditions

Interventions

DRUG

SUN-101 via eFlow nebulizer

50 mcg glycopyrrolate via Electronic Nebulizer

DRUG

SUN-101 via eFlow nebulizer with activated charcoal

50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal

DRUG

Seebri® Breezhaler®

63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI

DRUG

Seebri® Breezhaler® with activated charcoal

63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal

DRUG

Glycopyrrolate Injection

50 mcg glycopyrrolate via IV

Sponsors & Collaborators

  • Sunovion Respiratory Development Inc.

    lead INDUSTRY

Principal Investigators

  • Head of Global Clinical, Respiratory and Bio-threapeutics · Sunovion Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-04-30
Completion
2016-04-30

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 NCT02512302 on ClinicalTrials.gov