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A Randomised, Double-blind, Single Dose, Three Period, Complete Cross Over Trial in Healthy Subjects Investigating the Pharmacokinetics of Subcutaneous Injections of Somapacitan 5 mg/1.5 mL and 10 mg/1.5 mL

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Trial Profile

A Randomised, Double-blind, Single Dose, Three Period, Complete Cross Over Trial in Healthy Subjects Investigating the Pharmacokinetics of Subcutaneous Injections of Somapacitan 5 mg/1.5 mL and 10 mg/1.5 mL

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 17 Jul 2024

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At a glance

  • Drugs Somapacitan (Primary)
  • Indications Somatotropin deficiency
  • Focus Pharmacokinetics
  • Sponsors Novo Nordisk

    • Most Recent Events

    • 18 Jun 2023 Primary endpoint (Maximum serum concentration of somapacitan) has not been met.
    • 18 Jun 2023 Primary endpoint (Area under the somapacitan serum concentration time curve from time 0 to the time of the last quantifiable concentration after dosing) has been met.
    • 18 Jun 2023 Results assessing bioequivalence of somapacitan presented at the 105th Annual Meeting of the Endocrine Society

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