Pharmacodynamic/Pharmacokinetic Interactions Between Oral Roflumilast and Inhaled Formoterol
NCT ID: NCT00940329
Last Updated: 2016-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2004-04-30
2004-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment A
Roflumilast
Treatment A (500 μg/d roflumilast from day 2 to day 18 and 48 μg/d formoterol from day 12 to day 18)
Treatment B
Roflumilast
Treatment B (48 μg/d formoterol from day 2 to day 18 and 500 μg/d roflumilast from day 9 to day 18)
Interventions
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Roflumilast
Treatment A (500 μg/d roflumilast from day 2 to day 18 and 48 μg/d formoterol from day 12 to day 18)
Roflumilast
Treatment B (48 μg/d formoterol from day 2 to day 18 and 500 μg/d roflumilast from day 9 to day 18)
Eligibility Criteria
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Inclusion Criteria
* Normal body weight as indicated by a Body Mass Index (BMI) between 18 and 30 kg/m2 and a body weight \> 50 kg
* Assessed as healthy, based on a screening examination including medical history, physical examination, BP, PuR, ECG, and clinical laboratory results
* Caucasian
Exclusion Criteria
* Participant in any other study or donation of blood during the last 30 d before start of this study (last day of intake of medication - first day of medication in the following study)
* Any active disease, acute or chronic (also psychiatric diseases)
* Any signs or present history of cardiac diseases (e.g. QTc interval acc. to Bazett ≥ 430 ms, PQ ≥ 220 ms), in particular tachycardiac arrhythmia, third-degree AV-block, idiopathic-subvalvular aortic stenosis or hypertrophic-obstructive cardiomyopathia
* Proneness to symptomatic orthostatic dysregulation, fainting or "blackouts" (medical history), or to orthostatic hypotension defined by SBP \< 90 mm Hg (standing blood pressure, 30 s after raising up from a supine position)
* Gastrointestinal surgery except from appendectomy and herniotomy
* HIV or hepatitis screening positive or not performed (in case of a positive HIV test, the subject had to be informed by a physician in personal communication
* Drug screening positive or not performed
* Excessive xanthine consumption (more than 5 cups of coffee or equivalent per day)
* Non-compliance for measurements of impedance cardiography (feasibility was proven and documented at the screening visit by one test procedure)
18 Years
45 Years
MALE
Yes
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca AstraZeneca
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Nycomed
Konstanz, , Germany
Countries
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References
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de Mey C, Nassr N, Lahu G. No relevant cardiac, pharmacokinetic or safety interactions between roflumilast and inhaled formoterol in healthy subjects: an open-label, randomised, actively controlled study. BMC Clin Pharmacol. 2011 Jun 1;11:7. doi: 10.1186/1472-6904-11-7.
Related Links
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BY217-CP-059-RDS-2005-05-03.pdf
Other Identifiers
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BY217/CP-059
Identifier Type: -
Identifier Source: org_study_id