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Completed

NCT Number: NCT01386996

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orion Pharma Phase I Unit

Espoo, Finland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
  • 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.
  • Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
  • Known hypersensitivity to the active substance(s) or the excipient of the drug.
  • Pregnant or lactating females.

Treatment and study plan

Budesonide/formoterol Easyhaler 320/9 microg

Drug

2 inhalations as a single dose

Symbicort Turbuhaler forte

Drug

2 inhalations as a single dose

Primary outcomes

  1. Pharmacokinetic parameter Cmax of plasma budesonide concentration

    Time frame: within 12 h

  2. Pharmacokinetic parameter AUCt of plasma budesonide concentration

    Time frame: 12 h

  3. Pharmacokinetic parameter Cmax of plasma formoterol concentration

    Time frame: 24 h

  4. Pharmacokinetic parameter AUCt of plasma formoterol concentration

    Time frame: 24 h

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

Pharmacokinetic Study Comparing Two Budesonide/Formoterol Fumarate Dihydrate Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler 320/9 Microg/Inhalation and Symbicort Turbuhaler Forte; a Randomised, Double-blind, Single Centre, Single Dose, Crossover Study in Healthy Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 1, 2011
Registry last updated
Dec 22, 2011

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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