This ODM file contains the form to document the investigational product, the treatment confirmation and the randomisation-number. To be assessed at Day 1 of Period 1 and 2 (randomisation number only at Period 1). Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet Patient Level Data: Study Listed on Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

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  1. 10/8/18
  2. 10/11/18
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October 11, 2018

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Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396

Investigational Product, Treatment Confirmation, Randomisation-Number

Administrative Data
Visit Type
Investigational Product
Treatment Confirmation
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Randomisation number