Two drugs used for Attention Deficit Hyperactivity Disorder (ADHD)

• Research type

  Research Study

• Full title

  A Phase I, Randomised, Open-label, Two-period, Single-dose, Crossover Bioequivalence Study Of Two Capsule Strengths of SPD544 In Healthy Volunteers

• IRAS ID

  58793

• Contact name

  Muna Albayaty

• Sponsor organisation

  Shire Pharmaceutical Development Ltd.

• Eudract number

  2010-021227-27

• Research summary

  The two drugs to be administered in this study are both approved drugs for attention-deficit/hyperactivity disorder (ADHD). The registered trade names of the drugs are Equasym XL and Metadate CD. Equasym XL and Metadate CD are licensed and marketed within the European Union (EU) and the United States (US), respectively. This study is intended to support a supplementary marketing application for a higher strength capsule of Equasym XL within the EU. For the purposes of this study, the two drugs are collectively referred to as SPD544. Volunteers will receive one dose of each of the two study drugs during the study, so that the way that the drug is taken up by the body can be compared between the two drugs. The study drugs will be given in the form of capsules that will be swallowed by the volunteers. 24 healthy volunteers will be required to complete the study. The study will be performed at the PAREXEL Early Phase Clinical Unit, Northwick Park Hospital, Harrow. The volunteers will undergo the following procedures during the study: medical history and demographic data will be collected, height and weight will be measured, physical examinations and electrocardiograms (ECG) will be performed, vital signs (blood pressure and pulse rate) will be taken, safety blood and urine tests, serology, pregnancy tests and screens for alcohol and drugs of abuse will be done, blood will be tested to measure the concentration of study drug, a questionnaire called Columbia Suicide Severity Rating Scale (C-SSRS) which cover topics such as suicide-related thoughts and behaviours will be completed, and any adverse events that volunteers experience and other medication they take, will be recorded.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC01/19

• Date of REC Opinion

  24 Aug 2010

• REC opinion

  Further Information Favourable Opinion