Fasted Study to compare BE of Dutasteride & Tamsulosin HCI in males

• Research type

  Research Study

• Full title

  A Single-Dose, Randomised, Open-Label, Two-Period Crossover Study to Determine the Bioequivalence of the Second Generation Dutasteride and Tamsulosin HCI Combination Capsule in the Fasted State in Healthy Adult Male Subjects.

• IRAS ID

  132076

• Contact name

  Adrian Johnston Stewart

• Contact email

  adrian.stewart@celerion.com

• Sponsor organisation

  GlaxoSmithKline R&D Ltd

• Eudract number

  2013-001126-26

• Research summary

  The purpose of this study is to assess the bioequivalence of the second
  generation dutasteride and tamsulosin HCl combination capsule versus currently
  available commercial Duodart/Combidart in healthy adult male participants. This is a single dose, open label, randomized, 2-way crossover study. Participants will receive either a single oral dose of the second generation dutasteride (0.5 mg) and tamsulosin (0.4 mg) combination capsule or a single dose of Duodart/Combidart in with a 28-day washout period both in fasted state. Blood samples for pharmacokinetic analysis of dutasteride and tamsulosin serum concentrations will be taken at pre-specified times. Safety will be assessed by measurement of blood pressure, heart rate, laboratory tests, and collection of adverse events. The study will enroll approximately 92 healthy adult male participants in order to complete approximately 76 evaluable participants.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  13/NW/0396

• Date of REC Opinion

  4 Jul 2013

• REC opinion

  Further Information Favourable Opinion