Why the study?
Does a high-fat meal alter the pharmacokinetics of oral roflumilast in healthy subjects?
Does a high-fat meal alter the pharmacokinetics of oral roflumilast in healthy subjects?
A high-fat meal does not significantly affect the overall systemic exposure of roflumilast and its active metabolite, indicating it can be administered without regard to meals.
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Supports roflumilast dosing without regard to meals; confirms absence of clinically relevant food effect on exposure.
Hauns et al. (2006) studied this question.
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