Pharmacokinetic Study to Compare Absorption of Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler
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
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 asthma
Started Jan 2016
Shorter than P25 for phase_1 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 8, 2017
CompletedMarch 8, 2017
February 1, 2016
2 months
February 15, 2016
March 2, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Cmax of plasma budesonide and formoterol
within 24 hours
AUCt of plasma budesonide and formoterol
within 24 hours
Study Arms (4)
Charcoal and Budesonide/formoterol Easyhaler A
EXPERIMENTAL160/4.5microg/inhalation Charcoal
Charcoal and Budesonide/formoterol Easyhaler B
EXPERIMENTAL160/4.5microg/inhalation Charcoal
Charcoal and Budesonide/formoterol Easyhaler C
EXPERIMENTAL160/4.5microg/inhalation Charcoal
Charcoal and Symbicort Turbuhaler
ACTIVE COMPARATOR160/4.5microg/inhalation Charcoal
Interventions
2 inhalations as a single dose
2 inhalations as a single dose
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orion Pharma, Clinical Pharmacology Unit
Espoo, 02100, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Iissa Kivisto
Orion Corporation, Orion Pharma
- PRINCIPAL INVESTIGATOR
Leena Mattila, MD
Orion Pharma, Clinical Pharmacology Unit, Espoo, Finland
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2016
First Posted
March 8, 2017
Study Start
January 1, 2016
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
March 8, 2017
Record last verified: 2016-02