Plasma level comparison of two compounds given apart or in combination

• Research type

  Research Study

• Full title

  An open-label, randomized, three-period crossover, single dose study to compare the pharmacokinetics of the final EC905 formulation to marketed solifenacin (Vesicare®) and tamsulosin OCAS (Omnic OCAS®).(Parexel study no: 109077)

• IRAS ID

  47029

• Contact name

  Muna Albayaty

• Sponsor organisation

  Astellas Pharma Europe B.V.

• Eudract number

  2009-015618-22

• 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 3-period study will investigate the plasma concentrations after a single dose of the combined administration of solifenacin and tamsulosin compared to the plasma concentration of a single dose of the marketed medications of solifenacin respectively tamsulosin. The safety and tolerability of the combined administration and the single administration of the marketed medications will also be assessed. This study will enroll 30 healthy male participants aged between 18-55 years. p>

• REC name

  Scotland A REC

• REC reference

  10/IEC02/4

• Date of REC Opinion

  19 Mar 2010

• REC opinion

  Further Information Favourable Opinion