Bioavailability Study of 2 Formulations of Ramipril

• Research type

  Research Study

• Full title

  Comparative, Randomised, Single-Dose, 2-way Crossover Bioavailability Study of the Test Product, Rosemont Ramipril 2.5 mg/5 mL Oral Solution, and the Reference Product, Sanofi-Aventis (Tritace®) 2.5 mg Ramipril Tablet, in Healthy Adult Volunteers Under Fasting Conditions

• IRAS ID

  53230

• Contact name

  Stephen Smith

• Sponsor organisation

  Rosemont Pharmaceuticals

• Eudract number

  2010-020148-36

• Research summary

  The purpose of this study is to compare a new oral solution formulation of ramipril with the currently marketed Tritace© tablet. This study will find out how much of and the rate at which ramipril and its breakdown product ramiprilat 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 35 days between the two doses. Male and/or female volunteers (aged between 18-55 years) will take part in this study at one centre in the UK.

• REC name

  HSC REC A

• REC reference

  10/NIR01/18

• Date of REC Opinion

  30 Apr 2010

• REC opinion

  Favourable Opinion