bioavailability of 2 eprosartan formulations

• Research type

  Research Study

• Full title

  An open-label, single dose, randomized, four-way cross-over study to assess the relative bioavailability of a 450 mg eprosartan tablet in comparison to the marketed 600 mg tablet of eprosartan in healthy adult male subjects under fed and fasted condition

• IRAS ID

  52339

• Contact name

  James Ritter

• Sponsor organisation

  Abbott Healthcare Products BV (formerly Solvay Pharmaceuticals BV)

• Eudract number

  2010-019 430-27

• Research summary

  The drug being tested in this study, eprosartan, is licensed for the treatment of hypertension (high blood pressure). This study will investigate a new formulation of eprosartan under both fasted and fed conditions in healthy volunteers, in order to determine if it is better absorbed from the gut than is the licensed formulation. The study will take place at Quintiles Drug Research Unit. Up to 52 volunteers will participate in the trial. Each volunteer will attend the unit for 4 admission periods each of 4 days/3 nights duration, during which time they will receive eprosartan (licensed formulation) on 2 occasions and eprosartan (new formulation) on 2 occasions, once fasted and once fed.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  10/H0804/34

• Date of REC Opinion

  7 May 2010

• REC opinion

  Favourable Opinion