Comparison of Absorption of Budesonide and Formoterol From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler
Pharmacokinetic Study Comparing Two Budesonide/Formoterol Fumarate Dihydrate Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler 320/9 Microg/Inhalation and Symbicort Turbuhaler Forte; a Randomised, Double-blind, Single Centre, Single Dose, Crossover Study in Healthy Subjects
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 May 2012
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
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 4, 2012
CompletedFirst Posted
Study publicly available on registry
May 8, 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
CompletedNovember 22, 2012
November 1, 2012
5 months
May 4, 2012
November 21, 2012
Conditions
Outcome Measures
Primary Outcomes (4)
Pharmacokinetic parameter Cmax of plasma budesonide concentration
within 12 h
Pharmacokinetic parameter Cmax of plasma formoterol concentration
within 24 h
Pharmacokinetic parameter AUCt of plasma budesonide concentration
Within 12 h
Pharmacokinetic parameter AUCt of plasma formoterol concentration
Within 24 h
Study Arms (4)
Charcoal and Symbicort Turbuhaler
ACTIVE COMPARATORSymbicort Turbuhaler
ACTIVE COMPARATORCharcoal and Budesonide/formoterol Easyhaler
EXPERIMENTALBudesonide/formoterol Easyhaler
EXPERIMENTALInterventions
2 inhalations as a single dose
2 inhalations as a single dose
2 inhalations as a single dose
Eligibility Criteria
You may qualify if:
- Healthy males and females aged 18-60 years.
- Normal weight, at least 50 kg.
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)
Orion Pharma Clinical Pharmacology Unit
Espoo, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leena Mattila, MD, PhD
Orion Corporation, Orion Pharma
- STUDY DIRECTOR
Ulla Sairanen, MSc
Orion Corporation, Orion Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2012
First Posted
May 8, 2012
Study Start
May 1, 2012
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
November 22, 2012
Record last verified: 2012-11