Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte (ADECO)

October 12, 2012 updated by: Orion Corporation, Orion Pharma

Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte; a Randomised, Double-blind, Double-dummy, Single Centre, Single Dose, Crossover Study in Healthy Subjects

The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 1

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, 14050
        • 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

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Written informed consent (IC) obtained.
  2. Males and females, 18-60 (inclusive) years of age.

Exclusion Criteria:

  1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
  2. Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
  3. Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
  4. Known hypersensitivity to the active substance(s) or the excipient of the drug.
  5. 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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Budesonide/formoterol Easyhaler
Drug: Budesonide/formoterol Easyhaler
Budesonide/formoterol Easyhaler
ACTIVE_COMPARATOR: Symbicort Turbuhaler
Drug: Symbicort Turbuhaler
Symbicort Turbuhaler
EXPERIMENTAL: Charcoal and Budesonide/formoterol Easyhaler
Drug: Charcoal and Budesonide/formoterol Easyhaler
Charcoal and Budesonide/formoterol Easyhaler
ACTIVE_COMPARATOR: Charcoal and Symbicort Turbuhaler
Drug: Charcoal and Symbicort Turbuhaler
Charcoal and Symbicort Turbuhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameter Cmax of plasma budesonide concentration
Time Frame: within 12 h
within 12 h
Pharmacokinetic parameter AUCt of plasma budesonide concentration
Time Frame: 12 h
12 h
Pharmacokinetic parameter Cmax of plasma formoterol concentration
Time Frame: 24 h
24 h
Pharmacokinetic parameter AUCt of plasma formoterol concentration
Time Frame: 24 h
24 h

Collaborators and Investigators

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

Sponsor

Orion Corporation, Orion Pharma

Investigators

  • Study Director: Irja Korpela, MSc, Orion Corporation, Orion Pharma
  • Principal Investigator: Rainard Fuhr, Dr. med., Parexel Berlin

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

June 1, 2012

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

June 21, 2012

First Submitted That Met QC Criteria

June 22, 2012

First Posted (ESTIMATE)

June 25, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 15, 2012

Last Update Submitted That Met QC Criteria

October 12, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3103011

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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