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Bioequivalence of Alteplase Derived From Two Different Manufacturing Processes Following Intravenous Administration in Healthy Male Volunteers

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Trial Profile

Bioequivalence of Alteplase Derived From Two Different Manufacturing Processes Following Intravenous Administration in Healthy Male Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 28 Apr 2023

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At a glance

  • Drugs Alteplase (Primary)
  • Indications Catheter thrombosis; COVID 2019 infections; Deep vein thrombosis; Haemorrhage; Myocardial infarction; Pulmonary embolism; SARS-CoV-2 acute respiratory disease; Stroke
  • Focus Pharmacokinetics
  • Sponsors Boehringer Ingelheim

    • Most Recent Events

    • 05 Jul 2021 Status changed from recruiting to completed.
    • 05 May 2021 Planned number of patients changed from 60 to 72.
    • 19 Apr 2021 Number of treatment arms is increased from 2 to 3, by the addition of an open-label test arm and labelling it as Part A. The previously existing arms are labelled as Part B (Test and Reference) arms with sequential design.

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