A Randomized, Open-Label, Single- and Multiple-Dose, Four-Way Parallel Study Comparing the Fed and Fasted Pharmacokinetics of Two Dose Levels of Diazoxide Choline Controlled-Release Tablet (DCCR) in Healthy Volunteers.

Trial Profile

A Randomized, Open-Label, Single- and Multiple-Dose, Four-Way Parallel Study Comparing the Fed and Fasted Pharmacokinetics of Two Dose Levels of Diazoxide Choline Controlled-Release Tablet (DCCR) in Healthy Volunteers.

Withdrawn prior to enrolment
Phase of Trial: Phase I

Latest Information Update: 14 Sep 2016

At a glance

  • Drugs Diazoxide (Primary)
  • Indications Prader-Willi syndrome
  • Focus Pharmacokinetics
  • Sponsors Essentialis
  • Most Recent Events

    • 30 Aug 2016 Status changed from not yet recruiting to withdrawn prior to enrolment as the study did not support the planned development of DCCR in the new indication
    • 04 Nov 2010 Planned End Date changed from 2 Dec 2011 to 31 Mar 2011 as reported by ClinicalTrials.gov.
    • 04 Nov 2010 Planned initiation date changed from 1 Jul 2009 to 1 Mar 2011 as reported by ClinicalTrials.gov.
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