Phase I Pharmacokinetic Study (BF-BLOCK)
BF-BLOCK
Effect of Charcoal on Gastrointestinal Absorption of Budesonide and Formoterol
1 other identifier
interventional
20
1 country
1
Brief Summary
The objective of the study is to assess if charcoal prevents the absorption of budesonide and formoterol via GI track. The assessment will be based on comparing the pharmacokinetic parameter area under the concentration-time curve.
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 Aug 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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 23, 2011
CompletedFirst Posted
Study publicly available on registry
August 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedOctober 21, 2011
October 1, 2011
2 months
August 23, 2011
October 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The evaluation of primary pharmacokinetic variable AUCt
The evaluation of primary pharmacokinetic variable AUCt of this study will be based on statistical methods appropriate for crossover design.
4 weeks
Secondary Outcomes (2)
Pharmacokinetic variables
4 weeks
Pharmacokinetic variable
4 weeks
Study Arms (2)
Treatment A
EXPERIMENTALBudesonide/formoterol capsule (Orion Pharma) for oral administration.
Treatment B
EXPERIMENTALBudesonide/formoterol capsule (Orion Pharma) for oral administration.
Interventions
Oral administration without concomitant charcoal.
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, gastrointestinal, 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 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 excipients of the drug.
- Pregnant or lactating females.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Reseach Services Turku (CRST)
Turku, 20520, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mika Scheinin, M.D.Ph.D
Clinical Research Services Turku 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
August 23, 2011
First Posted
August 25, 2011
Study Start
August 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
October 21, 2011
Record last verified: 2011-10