Pharmacokinetic Pilot Study on Budesonide/Formoterol
Information source: Orion Corporation, Orion Pharma
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Budesonide (Drug); Formoterol (Drug); Easyhaler (Device); Turbohaler Forte (Device)
Phase: N/A
Status: Recruiting
Sponsored by: Orion Corporation, Orion Pharma Official(s) and/or principal investigator(s):
Johanna Hietamäki, MSc, Study Director, Affiliation: Orion Corporation, Orion Pharma
Overall contact:
R. Fuhr, MD, Phone: +4930 30685 414, Ext: 5414, Email: rainard.fuhr@parexel.com
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.
Clinical Details
Official title: Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler: A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Cmax of Budesonide and FormoterolAUCt of Budesonide and Formoterol
Secondary outcome: AUCinf of Budesonide and Formoteroltmax of Budesonide and Formoterol t1/2 of Budesonide and Formoterol
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
R. Fuhr, MD, Phone: +4930 30685 414, Ext: 5414, Email: rainard.fuhr@parexel.com
Parexel International GmbH, Berlin, Germany; Recruiting
Rainard Fuhr, MD, Phone: +4930 30685 414, Ext: 5414, Email: rainard.fuhr@parexel.com
Additional Information
Starting date: October 2011
Last updated: October 25, 2011
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