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CompletedNCT01593826Updated Nov 22, 2012

Comparison of Absorption of Budesonide and Formoterol From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler

A Phase 1 interventional study of Charcoal and Budesonide/formoterol Easyhaler 320/9 microg and Charcoal and Symbicort Turbuhaler in Asthma, sponsored by Orion Corporation, Orion Pharma. Completed at 1 site in Finland. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-11-22.

Sponsored by Orion Corporation, Orion Pharma · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Asthma
03

In context

Lead sponsor

Orion Corporation, Orion Pharma is the lead sponsor of 100 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy males and females aged 18-60 years.
  2. Normal weight, at least 50 kg.

Exclusion criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • Active comparator
    Charcoal and Symbicort Turbuhaler

    Drug: Charcoal and Symbicort Turbuhaler

  • Active comparator
    Symbicort Turbuhaler

    Drug: Symbicort Turbuhaler forte

  • Experimental
    Charcoal and Budesonide/formoterol Easyhaler

    Drug: Charcoal and Budesonide/formoterol Easyhaler 320/9 microg

  • Experimental
    Budesonide/formoterol Easyhaler

    Drug: Budesonide/formoterol Easyhaler 320/9 microg

Interventions

  • DrugCharcoal and Budesonide/formoterol Easyhaler 320/9 microg

    2 inhalations as a single dose

  • DrugCharcoal and Symbicort Turbuhaler

    2 inhalations as a single dose

  • DrugBudesonide/formoterol Easyhaler 320/9 microg

    2 inhalations as a single dose

  • DrugSymbicort Turbuhaler forte

    2 inhalations as a single dose

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic parameter Cmax of plasma budesonide concentration

    Time frame: within 12 h

  2. Pharmacokinetic parameter Cmax of plasma formoterol concentration

    Time frame: within 24 h

  3. Pharmacokinetic parameter AUCt of plasma budesonide concentration

    Time frame: Within 12 h

  4. Pharmacokinetic parameter AUCt of plasma formoterol concentration

    Time frame: Within 24 h

07

Study locations

1 site
  • Orion Pharma Clinical Pharmacology Unit
    Espoo, Finland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01593826
Lead sponsor
Orion Corporation, Orion Pharma
Responsible party
Sponsor
First posted
May 8, 2012
Start date
May 2012
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Nov 22, 2012

Study contacts

Leena Mattila, MD, PhD
principal investigator · Orion Corporation, Orion Pharma
Ulla Sairanen, MSc
study director · Orion Corporation, Orion Pharma

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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