Pharmacokinetic Pilot Study on Budesonide/Formoterol
Not Applicable
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01457716
- Lead Sponsor
- Orion Corporation, Orion Pharma
- 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 Symbicort turbuhaler.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
Inclusion Criteria
- Healthy males and females, 18-55 years of age.
- Normal weight at least 50 kg.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Budesonide/Formoterol Easyhaler A Budesonide - Budesonide/Formoterol Easyhaler A Formoterol - Budesonide/Formoterol Easyhaler A Easyhaler - Budesonide/Formoterol Easyhaler B Budesonide - Budesonide/Formoterol Easyhaler B Easyhaler - Budesonide/Formoterol Easyhaler C Easyhaler - Budesonide/Formoterol Turbohaler Forte Turbohaler Forte - Budesonide/Formoterol Easyhaler B Formoterol - Budesonide/Formoterol Turbohaler Forte Budesonide - Budesonide/Formoterol Easyhaler C Budesonide - Budesonide/Formoterol Easyhaler C Formoterol - Budesonide/Formoterol Turbohaler Forte Formoterol -
- Primary Outcome Measures
Name Time Method Cmax of Budesonide and Formoterol 24 hours AUCt of Budesonide and Formoterol 24 hours
- Secondary Outcome Measures
Name Time Method AUCinf of Budesonide and Formoterol 24 hours tmax of Budesonide and Formoterol 24 hours t1/2 of Budesonide and Formoterol 24 hours
Trial Locations
- Locations (1)
Parexel International GmbH
🇩🇪Berlin, Germany