Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics (KINECO)

February 12, 2010 updated by: Orion Corporation, Orion Pharma

Bioequivalence Study Comparing Two Budesonide/Formoterol Fumarate Dihydrate Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler 200/6 µg/Inhalation and Symbicort Turbohaler 200 µg/6 µg/Inhalation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 2
  • 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

  • United Kingdom
      • Manchester, United Kingdom, M23 9QZ
        • Medicines Evaluation Unit

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or females aged 18-60 years with documented diagnosis of asthma
  • Prebronchodilator forced expiratory volume in one second (FEV1) at least 80% of the predicted value
  • The asthma should be stable on the same regular treatment for at least 4 weeks before screening.

Exclusion Criteria:

  • Use of oral, parenteral or rectal corticosteroids within 4 weeks preceding the screening
  • Respiratory infection within 4 weeks preceding the screening
  • Any condition requiring regular concomitant treatment or likely to need concomitant treatment during the study with medicinal products which have pharmacokinetic interactions with budesonide
  • Any disorder or 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

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: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Budesonide/formoterol Easyhaler
Drug: budesonide and formoterol 200/6 microg
2 inhalations as a single dose
Other Names:
  • Symbicort Turbohaler 200/6 microg/inhalation
Drug: budesonide and formoterol 200/6 microg
2 inhalations as a single dose with the concurrent charcoal blockage
Other Names:
  • Symbicort Turbohaler 200/6 microg/inhalation
EXPERIMENTAL: Charcoal and Budesonide/formoterol EH
Drug: budesonide and formoterol 200/6 microg
2 inhalations as a single dose
Other Names:
  • Symbicort Turbohaler 200/6 microg/inhalation
Drug: budesonide and formoterol 200/6 microg
2 inhalations as a single dose with the concurrent charcoal blockage
Other Names:
  • Symbicort Turbohaler 200/6 microg/inhalation
ACTIVE_COMPARATOR: Symbicort Turbohaler
Drug: budesonide and formoterol 200/6 microg
2 inhalations as a single dose
Other Names:
  • Symbicort Turbohaler 200/6 microg/inhalation
Drug: budesonide and formoterol 200/6 microg
2 inhalations as a single dose with the concurrent charcoal blockage
Other Names:
  • Symbicort Turbohaler 200/6 microg/inhalation
ACTIVE_COMPARATOR: Charcoal and Symbicort Turbohaler
Drug: budesonide and formoterol 200/6 microg
2 inhalations as a single dose
Other Names:
  • Symbicort Turbohaler 200/6 microg/inhalation
Drug: budesonide and formoterol 200/6 microg
2 inhalations as a single dose with the concurrent charcoal blockage
Other Names:
  • Symbicort Turbohaler 200/6 microg/inhalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameters Cmax and AUCt of plasma budesonide and formoterol concentrations
Time Frame: within 24 h
within 24 h

Collaborators and Investigators

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

Sponsor

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

September 1, 2009

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

February 1, 2010

Study Registration Dates

First Submitted

August 24, 2009

First Submitted That Met QC Criteria

August 24, 2009

First Posted (ESTIMATE)

August 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 15, 2010

Last Update Submitted That Met QC Criteria

February 12, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3103002

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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