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Bioequivalence Study of Dutasteride Capsules-An Evaluation of the Bioequivalence of Dutasteride Capsule Manufactured at GSK Compared to Dutasteride Capsule Manufactured at Catalent in Healthy Japanese Male Subjects

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Trial Profile

Bioequivalence Study of Dutasteride Capsules-An Evaluation of the Bioequivalence of Dutasteride Capsule Manufactured at GSK Compared to Dutasteride Capsule Manufactured at Catalent in Healthy Japanese Male Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 25 Aug 2023

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At a glance

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

    • Most Recent Events

    • 01 Jan 2018 Primary endpoint (Maximal measured plasma concentration (Cmax) of dutasteride test product and reference product) has not been met, according to the results published in the Clinical Pharmacology in Drug Development
    • 01 Jan 2018 Primary endpoint (Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t) of dutasteride test product and reference product) has been met, according to the results published in the Clinical Pharmacology in Drug Development
    • 01 Jan 2018 Results published in the Clinical Pharmacology in Drug Development

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