Pharmacokinetic Pilot Study on Budesonide/Formoterol

February 2, 2012 updated by: Orion Corporation, Orion Pharma

Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler: A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Parexel International GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy males and females, 18-55 years of age.
  • Normal weight at least 50 kg.

Exclusion Criteria:

  • Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
  • Any condition requiring concomitant treatment (including vitamins and herbal products)or likely to need any concomitant treatment during the study
  • Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study.
  • Known hypersensitivity to the active substance(s) or to any of the excipients of the drug.
  • Pregnant or lactating females.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Budesonide/Formoterol Easyhaler A
Drug: Budesonide
Single inhalation
Drug: Formoterol
Single inhalation
Device: Easyhaler
Inhaler device
Experimental: Budesonide/Formoterol Easyhaler B
Drug: Budesonide
Single inhalation
Drug: Formoterol
Single inhalation
Device: Easyhaler
Inhaler device
Experimental: Budesonide/Formoterol Easyhaler C
Drug: Budesonide
Single inhalation
Drug: Formoterol
Single inhalation
Device: Easyhaler
Inhaler device
Active Comparator: Budesonide/Formoterol Turbohaler Forte
Drug: Budesonide
Single inhalation
Drug: Formoterol
Single inhalation
Device: Turbohaler Forte
Inhaler device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax of Budesonide and Formoterol
Time Frame: 24 hours
24 hours
AUCt of Budesonide and Formoterol
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
AUCinf of Budesonide and Formoterol
Time Frame: 24 hours
24 hours
tmax of Budesonide and Formoterol
Time Frame: 24 hours
24 hours
t1/2 of Budesonide and Formoterol
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orion Corporation, Orion Pharma

Investigators

  • Study Director: Johanna Hietamäki, MSc, Orion Corporation, Orion Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

September 28, 2011

First Submitted That Met QC Criteria

October 20, 2011

First Posted (Estimate)

October 24, 2011

Study Record Updates

Last Update Posted (Estimate)

February 3, 2012

Last Update Submitted That Met QC Criteria

February 2, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3103007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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