Trial Profile

A prospective bioequivalence trial to evaluate the pharmacokinetics of Lisdexamfetamine (Vyvanse) chewable tablet in patients with attention deficit hyperactivity disorder, under fasting and non-fasting state

Status: Completed

Phase of Trial: Phase II

Latest Information Update: 18 Apr 2016

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At a glance

18 Apr 2016 New trial record
14 Apr 2016 According to a Shire media release, based on the results of 2 trials - SHP489-126 and SHP489-127, the company submitted a NDA to the US FDA for Lisdexamfetamine dimesylate (Vyvanse) as a chewable tablet for patients who may have difficulty swallowing or opening a capsule.

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