Status:
COMPLETED
Pharmacokinetic Pilot Study on Budesonide/Formoterol
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The aim of the study is to assess and compare the Pharmacokinetic (PK) of Budesonide and Formoterol after administration of 3 different product variants of Budesonide/Formoterol Easyhalers and Symbico...
Eligibility Criteria
Inclusion
- Healthy males and females, 18-55 years of age.
- 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 condition requiring concomitant treatment (including vitamins and herbal products)or likely to need any concomitant treatment during the study
- Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study.
- Known hypersensitivity to the active substance(s) or to any of the excipients of the drug.
- Pregnant or lactating females.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01457716
Start Date
October 1 2011
End Date
December 1 2011
Last Update
February 3 2012
Active Locations (1)
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1
Parexel International GmbH
Berlin, Germany