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A double-blind, randomized, two-period, two treatment, fixed sequence, crossover (fed versus fasted) study to evaluate the effect of food on pharmacokinetics of CBD with robust ECG monitoring in Healthy Volunteers (HVs)

Trial Profile

A double-blind, randomized, two-period, two treatment, fixed sequence, crossover (fed versus fasted) study to evaluate the effect of food on pharmacokinetics of CBD with robust ECG monitoring in Healthy Volunteers (HVs)

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 25 Mar 2019

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At a glance

  • Drugs Cannabidiol (Primary)
  • Indications Graft-versus-host disease
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Registrational
  • Sponsors Kalytera Therapeutics
  • Most Recent Events

    • 25 Mar 2019 New source identified and integrated (Australian New Zealand Clinical Trials Registry)
    • 05 Oct 2018 New trial record
    • 20 Sep 2018 According to a Kalytera Therapeutics media release, data from the study will be required by the FDA for the treatment and prevention program of GVHD.
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