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Completed

NCT Number: NCT03073057

Pharmacokinetic Study to Compare Absorption of Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler

The purpose of this study is to compare Budesonide/formoterol Easyhaler test products 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, Clinical Pharmacology Unit

Espoo, 02100, Finland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Written informed consent obtained
  • Body mass index > 19 and < 30kg/m2, weight at least 50 kg
  • Good general health ascertained by detailed medical history, and laboratory and physical examinations

Exclusion criteria

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

Treatment and study plan

budesonide/formoterol

Drug

2 inhalations as a single dose

Other names: Budesonide/formoterol 160/4.5microg

Charcoal

Other

Symbicort Turbuhaler

Drug

2 inhalations as a single dose

Other names: Symbicort Turbuhaler 160/4.5 microg

Primary outcomes

  1. Cmax of plasma budesonide and formoterol

    Time frame: within 24 hours

  2. AUCt of plasma budesonide and formoterol

    Time frame: within 24 hours

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

Pharmacokinetic Pilot Study Comparing Three Formulations of Budesonide/Formoterol Easyhaler 160/4.5 Microg/Inhalation and Symbicort Turbuhaler: A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 8, 2017
Registry last updated
Mar 8, 2017

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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