A study to compare Dexamfetamine Sulphate Oral Liquid and Tablets

• Research type

  Research Study

• Full title

  An open label, randomised, two-period, two-sequence single dose crossover study to determine the comparative bioavailability of Dexamfetamine Sulphate oral Liquid and the reference product, Dexamfetamine Sulphate Tablets in healthy male and female volunteers.

• IRAS ID

  126710

• Contact name

  Girish Sharma

• Sponsor organisation

  Essential Pharmaceuticals

• Eudract number

  2013-000786-37

• ISRCTN Number

  to be applied for

• Research summary

  A drug company called Essential Pharmaceuticals is developing their own oral liquid version of the drug Dexamfetamine Sulphate. Dexamfetamine Sulphate tablets are currently being used to treat a number of medical conditions such as Attention-Deficit-Hyperactivity-Disorder (ADHD) and Narcolepsy (a sleeping disorder). However, this is the first time that the oral liquid will have been given to humans. The purpose of this study is to compare how Dexamfetamine Sulphate Oral liquid and Dexamfetamine Sulphate tablets act once inside the body, by measuring their levels in the blood after they have been taken. This will help us figure out the extent to which the new Dexamfetamine Sulphate Oral liquid becomes available to the body, compared to the already marketed Dexamfetamine Sulphate tablets after it is taken as a single dose. The population who are eligible to take part in the study are healthy, non-smoking volunteers, aged between 18 and 60 years, as determined by screening tests at Simbec.The study will consist of 2 treatment periods (running from Day -1 to 24 hours after dosing, including 2 overnight stays and 2 return visits 36 and 48 hours after dosing).

• REC name

  Wales REC 2

• REC reference

  13/WA/0076

• Date of REC Opinion

  15 Mar 2013

• REC opinion

  Favourable Opinion