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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