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A Phase I, Randomised, parallel group study to compare the bioavailability and establish bioequivalence between the Novel Recombinant Human Antithrombin Gamma and Plasma-Derived Antithrombin in Healthy Volunteers

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Trial Profile

A Phase I, Randomised, parallel group study to compare the bioavailability and establish bioequivalence between the Novel Recombinant Human Antithrombin Gamma and Plasma-Derived Antithrombin in Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 24 Sep 2019

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At a glance

  • Drugs Antithrombin gamma (Primary) ; Antithrombin III
  • Indications Antithrombin III deficiency; Disseminated intravascular coagulation
  • Focus Pharmacokinetics

Most Recent Events

  • 24 Sep 2019 New trial record
  • 06 Sep 2019 Primary endpoint (Area Under the curve (AUC48t)) has been met, according to the results published in the Clinical Drug Investigation.
  • 06 Sep 2019 Primary endpoint (Peak plasma concentration after the third dose (Cmax,day3)) has been met, according to the results published in the Clinical Drug Investigation

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