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Completed

NCT Number: NCT01457716

Pharmacokinetic Pilot Study on Budesonide/Formoterol

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parexel International GmbH

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Budesonide

Drug

Single inhalation

Formoterol

Drug

Single inhalation

Easyhaler

Device

Inhaler device

Turbohaler Forte

Device

Inhaler device

Primary outcomes

  1. Cmax of Budesonide and Formoterol

    Time frame: 24 hours

  2. AUCt of Budesonide and Formoterol

    Time frame: 24 hours

Secondary outcomes

  1. AUCinf of Budesonide and Formoterol

    Time frame: 24 hours

  2. tmax of Budesonide and Formoterol

    Time frame: 24 hours

  3. t1/2 of Budesonide and Formoterol

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 24, 2011
Registry last updated
Feb 3, 2012

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.

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