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Bioequivalence of Tablet Formulation of Dabigatran Etexilate Compared to Commercial Capsule Formulation Following Oral Administration in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Replicate Design in a Two-treatment, Four-period, Two-sequence Crossover Study)

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Bioequivalence of Tablet Formulation of Dabigatran Etexilate Compared to Commercial Capsule Formulation Following Oral Administration in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Replicate Design in a Two-treatment, Four-period, Two-sequence Crossover Study)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 09 Nov 2019

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At a glance

  • Drugs Dabigatran etexilate (Primary)
  • Indications Deep vein thrombosis; Embolism; Pulmonary embolism; Stroke; Venous thromboembolism
  • Focus Pharmacokinetics
  • Sponsors Boehringer Ingelheim

    • Most Recent Events

    • 30 Oct 2019 Results investigating bioequivalence (BE) of the novel DE tablet versus the commercial DE capsule and DE bioavailability (BA) under pretreatment with the PPI rabeprazole and assessing the effect of elevated pH on exposure to dabigatran using two trials (NCT03070171, and NCT03143166) published in the American Journal of Cardiovascular Drugs
    • 29 Jun 2017 Status changed from recruiting to completed.
    • 18 Apr 2017 Planned End Date changed from 1 Jul 2017 to 20 Jun 2017.

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