Pharmacokinetics and tolerability of sumatriptan after single-dose administration of a fixed-dose combination tablet of sumatriptan/naproxen sodium 85/500 mg followed two hours later by subcutaneous sumatriptan 4- or 6-mg injection: a randomized, open-label, three-period crossover study in healthy volunteers

Clinical Therapeutics
Alienor BergesSusan A McDonald

Abstract

Rescue medication options that are consistent with the product labeling for sumatriptan/naproxen sodium (S/N) and that have been permitted in >or=1 clinical trial include the use of a second tablet of S/N, sumatriptan tablets (to a total daily dose of 200 mg), and naproxen sodium tablets (within the maximum limits recommended in the labeling). Sumatriptan subcutaneous (SC) injection might be especially useful as rescue medication mostly because of its rapid onset of activity. The aim of this study was to assess the pharmacokinetics and tolerability of sumatriptan SC used as rescue medication after the administration of oral S/N for the treatment of migraine. This randomized, open-label, 3-period crossover study compared the exposure to sumatriptan (Cmax and AUC to 14 hours after the administration of the second dose [AUC(0-14)]) between 3 treatment regimens: an initial dose of S/N 85/500 mg followed 2 hours later by sumatriptan 4 or 6 mg SC (S/N + S4 and S/N + S6, respectively) (test), or sumatriptan 100 mg PO (2 tablets administered 2 hours apart) (S100 + S100) (reference). Healthy adults aged 18 to 55 years were randomly assigned to receive all 3 regimens in a randomized sequence. On day 1 of each treatment period, continuous...Continue Reading

References

Mar 1, 1997·British Journal of Clinical Pharmacology·S HoodS Hillis
Mar 2, 2002·Current Pain and Headache Reports·Reijo Salonen, Andrew Scott
May 25, 2005·Neurology·Nabih M Ramadan
Apr 12, 2007·Headache·Seymour Solomon

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Citations

Jan 5, 2011·Headache·John F Rothrock, Veronica Morey
Apr 21, 2016·The Cochrane Database of Systematic Reviews·Simon LawR Andrew Moore
Feb 18, 2012·The Cochrane Database of Systematic Reviews·Christopher J DerryR Andrew Moore

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