Clinical therapeutics
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Clinical therapeutics · Mar 2013
Randomized Controlled TrialSingle-dose pharmacokinetics of fentanyl sublingual spray and oral transmucosal fentanyl citrate in healthy volunteers: a randomized crossover study.
Fentanyl sublingual spray (FSS) is a novel fentanyl formulation recently developed for the treatment of breakthrough cancer pain, which is characterized by a fast onset and a relatively short duration. ⋯ Absorption of fentanyl in this study was faster and bioavailability was greater with FSS than with OTFC. The pharmacokinetic profile of the sublingual spray closely matches the duration of onset to pain intensity in a breakthrough cancer pain episode. These findings suggest that FSS is appropriate for the treatment of breakthrough cancer pain. ClinicalTrials.gov identifier: NCT01780233.
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Clinical therapeutics · Mar 2013
Randomized Controlled TrialEffects of food intake on the pharmacokinetic properties of mirabegron oral controlled-absorption system: a single-dose, randomized, crossover study in healthy adults.
Mirabegron is a β3-adrenoceptor agonist used for the treatment of overactive bladder. Mirabegron is formulated as an extended-release tablet using oral controlled-absorption system (OCAS) technology. ⋯ Mirabegron OCAS tablets exhibited a decrease in mirabegron plasma exposure with food that was independent of dose (50 or 100 mg) or gender but dependent on meal composition. A greater reduction in mirabegron exposure was observed after a low-fat breakfast compared with after a high-fat breakfast. Based on findings from previous studies, the effects of food observed in this study do not warrant dose adjustment in clinical practice. ClinicalTrials.gov identifier: NCT00939757.