Study to compare BE of Dutasteride & Tamsulosin HCI in male volunteers

  • 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 Fed State in Healthy Adult Male Subjects.

  • IRAS ID

    128999

  • Contact name

    Adrian Johnston Stewart

  • Contact email

    adrian.stewart@celerion.com

  • Sponsor organisation

    GlaxoSmithKline R&D Ltd

  • Eudract number

    2013-001125-49

  • 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 fed 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/0350

  • Date of REC Opinion

    3 Jul 2013

  • REC opinion

    Further Information Favourable Opinion