Comparison Study of Two Formulations of Hydroxyurea

• Research type

  Research Study

• Full title

  Comparative, Randomised, Single-Dose, 2-way Crossover Bioavailability Study of Hikma Pharmaceuticals and E. R. Squibb & Sons Limited (Hydrea®) 500 mg Hydroxyurea Capsules in Healthy Adult Male Volunteers under Fasting Conditions

• IRAS ID

  53580

• Contact name

  Johnston Stewart

• Sponsor organisation

  Hikma Pharmaceuticals

• Eudract number

  2010-020321-41

• Research summary

  The purpose of this study is to compare a new capsule formulation of hydroxyurea with the currently marketed Hydrea© capsule. This study will find out how much of and the rate at which hydroxyurea 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

  Scotland A REC

• REC reference

  10/IEC02/12

• Date of REC Opinion

  26 May 2010

• REC opinion

  Further Information Favourable Opinion