Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte
ADECO
1 other identifier
interventional
72
1 country
1
Brief Summary
The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler 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 P75+ for phase_1 asthma
Started Jun 2012
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
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 21, 2012
CompletedFirst Posted
Study publicly available on registry
June 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedOctober 15, 2012
October 1, 2012
4 months
June 21, 2012
October 12, 2012
Conditions
Outcome Measures
Primary Outcomes (4)
Pharmacokinetic parameter Cmax of plasma budesonide concentration
within 12 h
Pharmacokinetic parameter AUCt of plasma budesonide concentration
12 h
Pharmacokinetic parameter Cmax of plasma formoterol concentration
24 h
Pharmacokinetic parameter AUCt of plasma formoterol concentration
24 h
Study Arms (4)
Budesonide/formoterol Easyhaler
EXPERIMENTALBudesonide/formoterol Easyhaler
Symbicort Turbuhaler
ACTIVE COMPARATORSymbicort Turbuhaler
Charcoal and Budesonide/formoterol Easyhaler
EXPERIMENTALCharcoal and Symbicort Turbuhaler
ACTIVE COMPARATORInterventions
Charcoal and Budesonide/formoterol Easyhaler
Charcoal and Symbicort Turbuhaler
Eligibility Criteria
You may qualify if:
- Written informed consent (IC) obtained.
- Males and females, 18-60 (inclusive) years of age.
You may not qualify if:
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
- Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
- Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
- Known hypersensitivity to the active substance(s) or the excipient of the drug.
- Pregnant or lactating females.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PAREXEL International GmbH
Berlin, 14050, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Irja Korpela, MSc
Orion Corporation, Orion Pharma
- PRINCIPAL INVESTIGATOR
Rainard Fuhr, Dr. med.
Parexel Berlin
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2012
First Posted
June 25, 2012
Study Start
June 1, 2012
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
October 15, 2012
Record last verified: 2012-10