Plasma levels of combinations of two compounds in males over 45 years

• Research type

  Research Study

• Full title

  An open-label, randomised, two-way crossover multiple dose study to evaluate the steady state pharmacokinetics of the two final combination tablet formulations (EC905; tamsulosin HCl/ solifenacin succinate; 0.4mg/6 mg and 0.4 mg/9 mg) in healthy male volunteers over 45 years of age.

• IRAS ID

  46973

• Contact name

  Muna Albayaty

• Sponsor organisation

  Astellas Pharma Europe B.V.

• Eudract number

  2009-015078-36

• 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 study will investigate the plasma concentrations after multiple doses of two combined administrations of solifenacin and tamsulosin when given for 12 days (to reach a steady state situation) over two consecutive periods. The safety and tolerability of the combined administrations will also be assessed. This study will enroll 28 healthy middle-aged or elderly male participants aged 45-80 years.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC01/3

• Date of REC Opinion

  30 Mar 2010

• REC opinion

  Further Information Favourable Opinion