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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)

Trial Profile

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)

Completed
Phase of Trial: Phase I

Latest Information Update: 16 Jan 2019

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

    • 29 Jun 2017 Status changed from recruiting to completed.
    • 18 Apr 2017 Planned End Date changed from 1 Jul 2017 to 20 Jun 2017.
    • 18 Apr 2017 Planned primary completion date changed from 1 Jul 2017 to 16 Jun 2017.
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