Comparative bioavailability study of two formulations of methotrexate

• Research type

  Research Study

• Full title

  Comparative, Randomised, Single-Dose, 2-way Crossover Bioavailability Study of Rosemont Pharmaceuticals Ltd 5 mg/5 mL Methotrexate Oral Solution Following a 10 mg Dose and Pharmacia Limited (Maxtrex®) 10 mg Methotrexate Tablets in Healthy Adult Male Subjects Under Fasting Conditions

• IRAS ID

  122429

• Contact name

  Adrian Johnston Stewart

• Sponsor organisation

  Rosemont Pharmaceuticals Ltd

• Eudract number

  2012-005659-17

• Research summary

  The purpose of this study is to compare a new oral solution formulation of methotrexate with the currently marketed Pharmacia Limited (Maxtrex©) 10 mg Methotrexate Tablet. This study will find out how much of and the rate at which methotrexate gets into and is removed from the body from each of the 2 formulations. To investigate this, volunteers will receive a single dose of each of the 2 formulations in a random order on 2 separate occasions (i.e. 2 assessment periods) during the study. There will be an interval of at least 7 days between the two doses. Male volunteers (aged between 18-55 years) will take part in this study at one centre in the UK.

• REC name

  HSC REC B

• REC reference

  13/NI/0012

• Date of REC Opinion

  8 Mar 2013

• REC opinion

  Further Information Favourable Opinion