Study of food effect on plasma levels of two compounds

• Research type

  Research Study

• Full title

  An open-label, single dose, randomized, three-way cross-over study to evaluate the effect of food on the pharmacokinetics of solifenacin and tamsulosin administered as combination tablet EC905 in young, healthy male subjects.(Parexel Study no: 109076)

• IRAS ID

  46911

• Contact name

  Muna Albayaty

• Sponsor organisation

  Astellas Pharma Europe B.V.

• Eudract number

  2009-013419-36

• Research summary

  Men suffering from lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) may benefit from drug treatment. Some drugs are already available, but these may not alleviate both storage and voiding symptoms. This food-effect study will compare the plasma concentrations after a single dose of the combined administration of solifenacin and tamsulosin in healthy male volunteers when given in a fasted stated, after a low-fat breakfast and high-fat breakfast over 3 study periods. The safety and tolerability of the combined administration will also be assessed. This study will enroll 52 healthy male participants aged 18-55 years.

• REC name

  Scotland A REC

• REC reference

  10/IEC02/3

• Date of REC Opinion

  19 Mar 2010

• REC opinion

  Further Information Favourable Opinion