Why the study?
Does roflumilast exhibit dose-proportional pharmacokinetics between 250 and 500 microg doses in healthy subjects?
Population
15 healthy subjects
Comparison
Roflumilast 500 microg immediate-release tablets… vs Roflumilast 250 microg immediate-release tablets…
Design
RCT, randomized, 2-period, 2-sequence crossover, open
Follow-up
12 days
Authors
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Supports flexible 250-500 μg dosing without exposure concerns; confirms dose-proportional PK between these doses in healthy subjects.
Does roflumilast exhibit dose-proportional pharmacokinetics between 250 and 500 microg doses in healthy subjects?
Roflumilast demonstrates predictable, dose-proportional pharmacokinetics between 250 and 500 microg doses in healthy subjects.
Bethke et al. (2006) studied this question.
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