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Relative Bioavailability Study With Abediterol Administered Via Three Different Inhalation Devices in Healthy Volunteers.

NCT04199598 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-04-21

No results posted yet for this study

Summary

The study is intended to assess the relative bioavailability of 2 different abediterol nebulised formulations (test) and the dry powder formulation (reference). The study results will provide information on the pharmacokinetic (PK) profile following use of the 3 devices to be used in further clinical development.

Conditions

Interventions

DRUG

Abediterol (2.4 μg)

2.4 μg (delivered dose) abediterol via PARI LC SPRINT nebuliser

DRUG

Abediterol (4.8 μg)

4.8 μg (delivered dose) abediterol via PARI LC SPRINT nebuliser

DRUG

Abediterol (2.4 μg)

2.4 μg (delivered dose) abediterol via OMRON NE-C900-E nebuliser

DRUG

Abediterol (2.5 μg)

2.5 μg (nominal dose) abediterol via DPI, reference

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Dr. med. Rainard Fuhr · Parexel

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-28
Primary Completion
2020-04-03
Completion
2020-04-03

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

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 NCT04199598 on ClinicalTrials.gov