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Relative Bioavailability of Tablet Formulation of Dabigatran Etexilate With and Without Co-administration of Rabeprazole in Healthy Male Subjects (an Open-label, Single-dose, Two-period, Single-arm Study)

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Trial Profile

Relative Bioavailability of Tablet Formulation of Dabigatran Etexilate With and Without Co-administration of Rabeprazole in Healthy Male Subjects (an Open-label, Single-dose, Two-period, Single-arm 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) ; Rabeprazole
  • Indications Cardiomyopathies; Cardiovascular disorders; Deep vein thrombosis; Embolism; Gastrointestinal haemorrhage; Pulmonary embolism; Stroke; Vascular disorders; 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
    • 16 Aug 2017 Status changed from recruiting to completed.
    • 01 Jun 2017 Status changed from not yet recruiting to recruiting.

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