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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2016

Interventions

  • Drug: Budesonide/formoterol
    • 2 inhalations as a single dose
  • Other: Charcoal
  • Drug: Symbicort Turbuhaler
    • 2 inhalations as a single dose

Arms, Groups and Cohorts

  • Experimental: Charcoal and Budesonide/formoterol Easyhaler A
    • 160/4.5microg/inhalation Charcoal
  • Experimental: Charcoal and Budesonide/formoterol Easyhaler B
    • 160/4.5microg/inhalation Charcoal
  • Experimental: Charcoal and Budesonide/formoterol Easyhaler C
    • 160/4.5microg/inhalation Charcoal
  • Active Comparator: Charcoal and Symbicort Turbuhaler
    • 160/4.5microg/inhalation Charcoal

Clinical Trial Outcome Measures

Primary Measures

  • Cmax of plasma budesonide and formoterol
    • Time Frame: within 24 hours
  • AUCt of plasma budesonide and formoterol
    • Time Frame: within 24 hours

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Orion Corporation, Orion Pharma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Iissa Kivisto, Study Director, Orion Corporation, Orion Pharma
    • Leena Mattila, MD, Principal Investigator, Orion Pharma, Clinical Pharmacology Unit, Espoo, Finland

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