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Pharmacokinetic Pilot Study on Budesonide/Formoterol

NCT01457716 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2012-02-03

No results posted yet for this study

Summary

The aim of the study is to assess and compare the Pharmacokinetic (PK) of Budesonide and Formoterol after administration of 3 different product variants of Budesonide/Formoterol Easyhalers and Symbicort turbuhaler.

Conditions

  • Healthy

Interventions

DRUG

Budesonide

Single inhalation

DRUG

Formoterol

Single inhalation

DEVICE

Easyhaler

Inhaler device

DEVICE

Turbohaler Forte

Inhaler device

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Johanna Hietamäki, MSc · Orion Corporation, Orion Pharma

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2011-11-30
Completion
2011-12-31

Countries

  • Germany

Study Locations

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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 NCT01457716 on ClinicalTrials.gov