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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

Completed
Phase of Trial: Phase I

Latest Information Update: 16 Aug 2018

At a glance

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

    • 16 Aug 2018 According to an Evoke Pharma media release, NDA for Gimoti for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis has been accepted for review by the U.S. FDA and set a target goal date under the Prescription Drug User Fee Act (PDUFA) of April 1, 2019.
    • 04 Jun 2018 According to an Evoke Pharma media release, the company has submitted 505(b)(2) New Drug Application (NDA) to the US FDA for Gimoti (metoclopramide) nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis.
    • 07 Mar 2018 According to an Evoke Pharma media release, the Company has confirmed the proposed dose for women to be submitted in the NDA, based on the results of this trial.
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