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An Open-label, Randomized, Single Dose, Two-way Crossover Study to Determine the Bioavailability of One Fixed Dose Combination Capsule Formulation of Dutasteride and Tamsulosin Hydrochloride (0.5 mg/0.2 mg) Relative to Coadministration of One Dutasteride 0.5 mg Capsule and One Tamsulosin Hydrochloride 0.2 mg Tablet in Healthy Male Subjects in the Fed and Fasted States

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Trial Profile

An Open-label, Randomized, Single Dose, Two-way Crossover Study to Determine the Bioavailability of One Fixed Dose Combination Capsule Formulation of Dutasteride and Tamsulosin Hydrochloride (0.5 mg/0.2 mg) Relative to Coadministration of One Dutasteride 0.5 mg Capsule and One Tamsulosin Hydrochloride 0.2 mg Tablet in Healthy Male Subjects in the Fed and Fasted States

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 26 Aug 2023

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At a glance

  • Drugs Dutasteride/tamsulosin (Primary) ; Dutasteride; Tamsulosin
  • Indications Benign prostatic hyperplasia
  • Focus Pharmacokinetics
  • Sponsors GlaxoSmithKline; GSK

    • Most Recent Events

    • 01 May 2018 Results of relative bioavailability of utasteride/tamsulosin data by using two studies including this study published in the Clinical Pharmacology in Drug Development.
    • 13 Nov 2015 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 04 Sep 2015 Status changed from not yet recruiting to recruiting as reported by ClinicalTrials.gov.

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