Pharmacokinetic Study to Compare Absorption of Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler
NCT ID: NCT03073057
Last Updated: 2017-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2016-01-31
2016-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Absorption of Budesonide and Formoterol From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler
NCT01593826
Comparison of Budesonide and Formoterol Absorption From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler
NCT01386996
Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte
NCT01627158
Pharmacokinetic Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers
NCT01668121
Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics
NCT00964535
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Charcoal and Budesonide/formoterol Easyhaler A
160/4.5microg/inhalation Charcoal
Budesonide/formoterol
2 inhalations as a single dose
Charcoal
Charcoal and Budesonide/formoterol Easyhaler B
160/4.5microg/inhalation Charcoal
Budesonide/formoterol
2 inhalations as a single dose
Charcoal
Charcoal and Budesonide/formoterol Easyhaler C
160/4.5microg/inhalation Charcoal
Budesonide/formoterol
2 inhalations as a single dose
Charcoal
Charcoal and Symbicort Turbuhaler
160/4.5microg/inhalation Charcoal
Charcoal
Symbicort Turbuhaler
2 inhalations as a single dose
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Budesonide/formoterol
2 inhalations as a single dose
Charcoal
Symbicort Turbuhaler
2 inhalations as a single dose
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Orion Corporation, Orion Pharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Iissa Kivisto
Role: STUDY_DIRECTOR
Orion Corporation, Orion Pharma
Leena Mattila, MD
Role: PRINCIPAL_INVESTIGATOR
Orion Pharma, Clinical Pharmacology Unit, Espoo, Finland
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Orion Pharma, Clinical Pharmacology Unit
Espoo, , Finland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
3103014
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.