Study identifier:BY217/CP-059
ClinicalTrials.gov identifier:NCT00940329
EudraCT identifier:N/A
CTIS identifier:N/A
Investigation on the cardiovascular and pharmacokinetic interaction between oral roflumilast and inhaled formoterol in healthy subjects
Healthy
Phase 1
Yes
Roflumilast
Male
27
Interventional
18 Years - 45 Years
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Sept 2016 by AstraZeneca
AstraZeneca
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This Phase I, open, randomized controlled, multiple-dose, parallel-group study investigated the potential pharmacodynamic and pharmacokinetic interactions between multiple doses of oral roflumilast and inhaled formoterol. Healthy male subjects were assigned to treatment A or treatment B. Subjects in treatment A received 500 μg/d roflumilast from day 2 to day 18 and 48 μg/d formoterol from day 12 to day 18. Subjects in treatment B received 48 μg/d formoterol from day 2 to day 18 and 500 μg/d roflumilast from day 9 to day 18. Impedance cardiography, ECG, serum potassium and glucose concentrations and effects on blood eosinophils assessed potential pharmacodynamic interactions. In addition, the safety and tolerability were evaluated. Pharmacokinetic parameters were assessed for roflumilast, roflumilast N-oxide, and formoterol.
Location
Location
Konstanz, Germany, 78467
Arms | Assigned Interventions |
---|---|
Active Comparator: Treatment A | Drug: Roflumilast Treatment A (500 μg/d roflumilast from day 2 to day 18 and 48 μg/d formoterol from day 12 to day 18) |
Active Comparator: Treatment B | Drug: Roflumilast Treatment B (48 μg/d formoterol from day 2 to day 18 and 500 μg/d roflumilast from day 9 to day 18) |
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