Skip to main content
OpenTrials
Completed

NCT Number: NCT00964535

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Medicines Evaluation Unit

Manchester, M23 9QZ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

budesonide and formoterol 200/6 microg

Drug

2 inhalations as a single dose

Other names: Budesonide/formoterol Easyhaler 200/6 microg/inhalation

Primary outcomes

  1. Pharmacokinetic parameters Cmax and AUCt of plasma budesonide and formoterol concentrations

    Time frame: within 24 h

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

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

Acronym: KINECO

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 25, 2009
Registry last updated
Feb 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.