Comparison of Budesonide and Formoterol Absorption 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
74
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 Jul 2011
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2011
CompletedFirst Posted
Study publicly available on registry
July 1, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedDecember 22, 2011
December 1, 2011
4 months
June 23, 2011
December 21, 2011
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)
Charcoal and Budesonide/formoterol Easyhaler
EXPERIMENTALCharcoal and Symbicort Turbuhaler
ACTIVE COMPARATORBudesonide/formoterol Easyhaler
EXPERIMENTALSymbicort Turbuhaler
ACTIVE COMPARATORInterventions
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 Phase I Unit
Espoo, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ulla Sairanen, MSc
Orion Corporation, Orion Pharma
- PRINCIPAL INVESTIGATOR
Kimmo Ingman, MD, PhD
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
June 23, 2011
First Posted
July 1, 2011
Study Start
July 1, 2011
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
December 22, 2011
Record last verified: 2011-12