Status:
COMPLETED
Phase I Pharmacokinetic Study (BF-BLOCK)
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Asthma
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 unde...
Eligibility Criteria
Inclusion
- Healthy males and females aged 18-60 years.
- Normal weight at least 50 kg.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01423305
Start Date
August 1 2011
End Date
October 1 2011
Last Update
October 21 2011
Active Locations (1)
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1
Clinical Reseach Services Turku (CRST)
Turku, Finland, 20520