A single dose, crossover comparative exposure pharmacokinetic (PK) trial of metoclopramide nasal spray to demonstrate bioequivalence of Gimoti in healthy volunteers

Trial Profile

A single dose, crossover comparative exposure pharmacokinetic (PK) trial of metoclopramide nasal spray to demonstrate bioequivalence of Gimoti in healthy volunteers

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Sep 2017

At a glance

  • Drugs Metoclopramide (Primary)
  • Indications Diabetic gastroparesis
  • Focus Pharmacokinetics; Registrational
  • Sponsors Evoke Pharma
  • Most Recent Events

    • 12 Sep 2017 Status changed from recruiting to active, no longer recruiting, according to an Evoke Pharma media release.
    • 12 Sep 2017 According to an Evoke Pharma media release, company announced that it has completed subject dosing for this comparative exposure pharmacokinetic (PK) study.
    • 14 Aug 2017 According to an Evoke Pharma media release, the 505(b)(2) New Drug Application (NDA) for Gimoti is being prepared in partnership with Rho, a well-established Contract Research Organization (CRO).
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