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首页> 外文期刊>Clinical drug investigation >Pharmacokinetics of Coadministered Viloxazine Extended-Release (SPN-812) and Methylphenidate in Healthy Adults
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Pharmacokinetics of Coadministered Viloxazine Extended-Release (SPN-812) and Methylphenidate in Healthy Adults

机译：共同升降的Viloxazine延长（SPN-812）和健康成人甲基酚的药代动力学

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摘要

Background and Objectives Viloxazine extended-release (viloxazine ER, SPN-812) is a novel non-stimulant with activity at serotonin receptors and the norepinephrine transporter, which is under investigation as a potential treatment for attention-deficit/hyperactivity disorder. Given the potential for viloxazine ER to be coadministered with other pharmacotherapies, this trial investigated the pharmacokinetics and safety of combination viloxazine ER + methylphenidate versus viloxazine ER or methylphenidate alone. Methods In this single-center, crossover, open-label trial, healthy adult participants received oral administration of 700 mg viloxazine ER alone, 36 mg methylphenidate alone, and combination viloxazine ER (700 mg) + methylphenidate (36 mg), with blood samples collected over 4 days post-administration. The active drug in viloxazine ER (viloxazine) and methylphenidate was measured using chromatographic tandem mass spectrometry. Safety assessments included adverse events (AEs), vital signs, echocardiograms, and clinical laboratory evaluations. Results Of 36 healthy adults who were enrolled, 34 completed the trial. The geometric least squares mean ratios are reported as [combination/single drug (90% confidence intervals)]. For viloxazine ER, maximum measured plasma concentration (C-max) = 100.98% (96.21-105.99), area under the concentration-time curve from time zero to the last measurable time (AUC(t)) = 98.62% (96.21-101.08), and area under the concentration-time curve from time zero to infinity (AUC(infinity)) = 98.96% (96.55-101.44). For methylphenidate, C-max = 103.55% (97.42-110.07), AUC(t) = 106.67% (101.01-112.64), and AUC(infinity) = 106.61% (100.99-112.54). All reported AEs were mild in severity. Conclusions Coadministration of viloxazine ER and methylphenidate did not impact the pharmacokinetics of viloxazine or methylphenidate relative to administration of either drug alone. The combination appeared to be safe and well tolerated.
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  • 来源
    《Clinical drug investigation》 |2021年第2期|共11页
  • 作者

    Faison Shamia L.; Fry Nicholas; Adewole Toyin; Odebo Oyinkansola; Schwabe Stefan; Wang Zhao; Maletic Vladimir; Nasser Azmi;

  • 作者单位

    Supernus Pharmaceut Inc 9715 Key West Ave Rockville MD 20850 USA;

    Supernus Pharmaceut Inc 9715 Key West Ave Rockville MD 20850 USA;

    Supernus Pharmaceut Inc 9715 Key West Ave Rockville MD 20850 USA;

    Supernus Pharmaceut Inc 9715 Key West Ave Rockville MD 20850 USA;

    Supernus Pharmaceut Inc 9715 Key West Ave Rockville MD 20850 USA;

    Supernus Pharmaceut Inc 9715 Key West Ave Rockville MD 20850 USA;

    Univ South Carolina Dept Psychiat Behav Sci Sch Med Greenville SC USA;

    Supernus Pharmaceut Inc 9715 Key West Ave Rockville MD 20850 USA;

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  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 药学;
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